adjunctive terapi for chronic wound

Upload: vonny-nurmalya-megawati

Post on 07-Jul-2018

219 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    1/167

     

    Health Services Advisory Council

    Evidence Summaries and Legislative Reports 

    A - G

    Select the individual report by clicking on the report name in thebookmarks list to the left of this page.

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    2/167

     

     Adjunctive Therapies forChronic Wounds

     Electrical Stimulation Electromagnetic Therapy 

    Health Services Advisory CouncilEvidence Summary  

    September 10, 2009

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    3/167

     

    This information is available in alternative formats to individuals withdisabilities by calling (651) 431-2203. TTY users can call throughMinnesota Relay at (800) 627-3529. For Speech-to-Speech, call(877) 627-3848. For additional assistance with legal rights and

    protections for equal access to human services programs, contactyour agency’s ADA coordinator. 

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    4/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     AbstractIn response to a 2008-2009 bill that would have mandated coverage for a wound care protocol thatincluded pulsed electromagnetic field (PEMF) therapy, as well as other, unknown, adjunctive

    treatments, this report has been created to evaluate the safety and effectiveness of specific adjunctivetherapies, including PEMF, for chronic wounds. There is currently no consistent evidence thatPEMF or electrical stimulation has benefit beyond standard therapy for patients with pressure ulcersor venous leg ulcers.

    Background/Context

    Policy Context

    Over the past two years, private industry has proposed a bundled set of wound care services theyhave called a “wound care formulary.” These initiatives have included three legislative proposals as well as a number of proposals to participate in a state-funded grant program for continuing carefacilities, and are described below:

    Pay for Performance Program:  The Performance Incentive Payment System at the MinnesotaDepartment of Human Services (DHS) solicits proposals to improve the quality and efficiency ofMinnesota’s long-term care system, and provides a maximum 5% performance-based rate adjustmentto participants. Since 2006, ten applications have been made to the program for “wound careformulary” programs including PEMF; two proposals have been approved.

    Bill HF 3617:  In the 2008-2009 Minnesota legislative session, a bill (HF 3617)1 was introduced torequire a 3-year demonstration project at all state veterans homes. (See Figure 1 for the completetext.) A private vendor with “wound formulary” expertise would be contracted to administer the

    program, and would be paid a per diem for patients in the veterans homes. The specifics of the“formulary” were not disclosed. If healing targets were not met, the per diem would be reduced by20%. The bill did not pass.

    SF 9961: In the 2008-2009 Minnesota legislative session, an amendment (SF 9961) 2 to the omnibusbill was introduced to implement a demonstration project for all enrollees in MHCP who haddiabetes or were at risk for diabetes. See Figure 2 for the complete text of this bill.) The project would provide podiatric wound care to at least 1000 recipients for a two year period. The specifictherapies in the program, and the mechanisms to identify patients for treatment were not disclosed.

    Bill HF 730:  In this same 2008-2009 session, another bill (HF 730 Thao, SF 688 Lynch) 3  wasintroduced to require coverage of a wound care protocol called “formulary-based wound care.” (See

    Figure 3 for the complete text of this bill.) The bill would have required all health plans, includingMHCP, to cover a bundled wound care “formulary” in all outpatient and nursing care facilities ifprescribed by a physician or advanced nurse. The specific treatments included in the “formulary” were not disclosed, except that it included electromagnetic therapy. The bill did not pass.

     Attempts have been made (3/10/2009, 3/30/2009, 6/10/2009, and 6/11/2009) by DHS staff toidentify the services, medical supplies, equipment and prescription drugs that are included in thisprotocol, the bundled product of one company, Advanced Healing Systems. One treatmentmodality, pulsed electromagnetic field (PEMF) therapy, has been identified as part of this protocol.

    2

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    5/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    In an effort to ensure that decisions regarding coverage policy for health care services are made usingthe best available research on their safety and effectiveness, this report has been created to evaluatethe benefit of specific adjunctive therapies, including PEMF, for chronic wounds.

    Chronic WoundsHealth care providers are faced with the challenge of treating an increasing number of patients whohave chronic wounds. The term chronic wound generally describes any interruption in the body’ssurface that requires a prolonged time to heal, does not heal, or recurs. The most common chronic wounds are those resulting from the consequence of diabetes, arterial and/or venous disease,sustained pressure (typically from being bed- or chair-bound), and as a result of therapeuticirradiation for the treatment of tumors.4 

    Chronic wounds are more common in the elderly, and for individuals with chronic multiple healthproblems. The prevalence of chronic skin ulcers has been estimated at 120 ulcers per 100,000patients between the ages of 45 and 64; prevalence increases to more than 800 ulcers per 100,000patients over age 75. Because of the increasing population of elderly individuals, as well asindividuals with diabetes, the prevalence of chronic wounds is likely to increase significantly in thefuture.5 

    In the Minnesota fee-for-service Medicaid population between 2006 and 2008, wound-care relatedprofessional claims, and the number of distinct recipients receiving professional wound caretreatment has steadily increased. Total reimbursement from professional claims has also increasedyearly, but total reimbursement saw a spike in 2007, driven by an increase in facility claims that year.During this same time period, the total reimbursement for amputations rose by 60%.

    See the tables below for an analysis of treatment costs, utilization rates, and amputationreimbursements for fee for service recipients with multiple wound visits. a 

     Treatment Costs for FFS Recipients with Multiple Wound Visits

    Fiscal Year Reimbursement fromProfessional Claims

    Reimbursement Amount fromFacility Claims (Inpt & Outpt)

     Total Reimbursement

    2006 $515,628 $8,654,822 $9,170,4502007 $639,262 $10,293,940 $10,933,2022008 $688,744 $8,680,432 $9,369,177

    a These data are extracted from the Medicaid Management Information System II (MMIS-II), and refer to fee-for-servicepatients enrolled in the Minnesota Health Care Programs (MHCP) who presented with two or more wound diagnosis visitsduring fiscal years 2006 to 2008, inclusive. Diagnoses included abscesses, chronic skin ulcers, open wounds, and non-healing surgical wounds. Procedures associated with these diagnoses included all codes for debridement, active wound caremanagement, physician supervision of hyperbaric oxygen therapy, dressings, and pressure-reducing support surfaces.

     Amputation procedures are shown separately.

     This includes professional fees and facility fees. This does not include wound care services that are included in their perdiem payment for patients in long term care facilities.

    3

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    6/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     Wound Care Utilization in the FFS PopulationFiscal Year # FFS Enrollees # Distinct Recipients

    Receiving Professional Wound Care

    # Distinct RecipientsReceiving Professional Wound Care per 1000 FFSEnrolled Population

    2006 528,956 1,195 2.262007 545,240 1,315 2.412008 557,384 1,347 2.42

    Lower Limb Amputations in the FFS PopulationFiscal Year # Distinct

    Recipients HavingLower Limb Amputations

    # Amputations Reimbursement Amount

    2006 77 121 $1,295,9092007 78 108 $1,619,6902008 99 160 $2,070,052

    Pressure UlcersPressure ulcers, one type of chronic wound, are estimated to affect 1.3 – 3 million individuals in theUnited States.6  Pressure ulcers (also called bed sores or pressure sores) are caused when sustainedpressure cuts off circulation to vulnerable parts of the body, especially the soft tissue near bony areassuch as the buttocks, hips and heels when the person sits or lies down. The skin of an immobile,bed- or chair-ridden person is more likely to be affected by pressure and shear. The tissue ischemia,or restricted blood supply, becomes a source of discomfort and pain. Unless there is adequate bloodflow, the affected tissue dies. Ischemic cell death produces inflammations and deep tissue necrosisthat result in a loss of volume disproportionately greater than the overlying skin defect.7  These wounds can develop quickly, progress rapidly, and are often difficult to heal.

    Staging for Pressure Ulcers 

     The recommendations regarding staging are put forth by the AHCPR Supported Clinical PracticeGuideline on Treatment of Pressure Ulcers. 8  Numerical identification of stages does not necessarilyimply a progression in ulcer severity. For example, a Stage I ulcer may have very little tissue damageor it may have necrotic underlying tissue, because muscle tissue is more sensitive than skin topressure-induced ischemia. Pressure ulcers are staged as follows:

      Stage I: Nonblanchable erythema of intact skin, the heralding lesion of skin ulceration. Inindividuals with darker skin, discoloration of the skin, warmth, edema, induration, or hardnessmay also be indicators.

      Stage II: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficialand presents clinically as an abrasion, blister, or shallow crater.

      Stage III: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that

    may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deepcrater with or without undermining of adjacent tissue.

      Stage IV: Full thickness skin loss with extensive destruction, tissue necrosis, or damage tomuscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tractsalso may be associated with Stage IV pressure ulcers.

    4

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    7/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     Venous Ulcers Venous ulcers, (also known as stasis, or varicose ulcers) another type of chronic leg wound, cause 80to 85% of all leg ulcers.9  These are usually located low on the inner ankle. They can occur higher onthe leg after an injury, but are never higher than the knee. More than one ulcer can occur at a time. Venous ulcers are usually tender to the touch, shallow, have a red appearance at the bottom, andoccasionally ooze material. The application of external compression reverses the increased

    hydrostatic pressure in the veins of the leg, and generally leads to the healing of venous leg ulcers.However, for the proportion of patients whose ulcers do not heal with compression therapy,adjunctive treatments are considered.

    Adjunctive Therapies

     Treatment strategies for chronic wounds can be both costly and complex. Hundreds of therapies arecurrently promoted, and some have been evaluated in randomized controlled trials (RCTs).10  Available evidence regarding the technologies of electromagnetic therapy and electrical stimulation was reviewed for this report.

     These methodologies are used as adjunct treatments in combination with standard wound caretreatments (e.g., debridement, compression for venous leg ulcers, patient rotation for pressure ulcers,restoration of blood flow to the affected area, treatment of infection, and proper nutrition.)11 Maintenance of a moist wound environment is a critical treatment goal that is usually achieved withmodern synthetic wound dressings.

     Wounds and Electrical Current Wounds have a weak, but measurable, current, called the current of injury or demarcation current. This is set up whenever injured tissue is adjacent or connected to uninjured tissue.  12  The injuredtissue is negative to the uninjured, and the current is driven toward the wound. It is unknown whether the current of injury plays a role in stimulating wound healing, or is merely a byproduct ofthe injured tissue.

    It is hypothesized that electrical stimulation may mimic or enhance the current of injury and possibly

    accelerate wound healing. Other theorized mechanisms for action include: increased migration ofcells to the wound; stimulation of cell proliferation, increased expression of growth factors and theirreceptors; improved blood flow; and increased collagen production and strength.13  For this reason,electrical stimulation has been studied as a possible therapy for accelerating wound healing.

    Electrical StimulationElectrical stimulation is achieved by placing electrodes close to the wound and applying directcurrent. There are three general types of electrical stimulation: low intensity direct current (LIDC),low intensity pulsed direct current (LIPDC), and high voltage pulsed current (HVPC).

    Electromagnetic TherapyIn electromagnetic therapy, electromagnetic fields, rather than electric current, are applied to the

     wound area. Electromagnetic therapy is distinct from most other forms of electrotherapy in that it isa field effect and not a direct electrical effect or form of radiation. However, the low-level magneticfield that is applied in electromagnetic therapy induces a low-level non-thermal electrical field. 14  The wide spectrum of the electromagnetic band includes the form of Short Wave Diathermy (SWD) thatis used therapeutically. SWD can be applied continuously or in short bursts of energy called pulsedshort wave diathermy (PSWD).15  This procedure is also referred to as pulsed electromagneticinduction (PEMI), or pulsed electromagnetic frequency (PEMF).

    5

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    8/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Summary of the Evidence The evidence reviewed for this document is considered separately for electrical stimulation andelectromagnetic therapy.

    Electrical Stimulation A number of summary documents have studied the use of electrical stimulation for patients withchronic wounds. The summary documents utilize a number of the same clinical trials for theiranalyses. A chart of these clinical trials and the summary documents that refer to them is providedbelow in Chart 1. More detailed analysis of these studies can be found in Table 1.

    Chart 1: Clinical Trials of Electrical Stimulation Included in Summary Documents

    Year  Document Name    A   d  u  n  s   k  y   2   0   0   5

       B  a   k  e  r   1   9   9   6

       B  a   k  e  r   1   9   9   7

       C  a  r   l  e  y   (   1   9   8   5   )

       F  e

      e   d  a  r   (   1   9   9   1   )

       G  a  r   d  n  e  r   1   9   9   9

       G  e  n  t  z   k  o  w   1   9   9   1

       G  o   l   d  m  a  n   2   0   0   4

       G  r   i   f   f   i  n   1   9   9   1

       J  a  n   k  o  v   i  c   2   0   0   8

       J  u  n  g  e  r   2   0   0   8

       K   l  o  t   h   1   9   8   8

       W

      o  o   d   1   9   9   3

    Conclusion

    1998

     AHCPR Guideline (1994,

    1998 memo) x x x x x   -

    2001 NHS - Tech Assessment x x x   +/-

    2002 CMS Decision Memo x x x x x x   +

    2006

     Wound Healing Society

    Guideline x x x   +

    2008 BMJ SR  x x x x   +

    2008 JAMA SR  x   -

    2009 ECRI Hotline Response x x x x   +/- 

     A 1998 memo from AHRQ (cited in the 2002 CMS Decision Memo)  16 stated that its 1994 Agencyfor Health Care Policy and Research (AHCPR) Guideline.17   recommendation to consider electricalstimulation for treatment was based on level B evidence from 5 clinical trials involving 147 patients(not all receiving the treatment). “These studies were not adequately powered or persuasive becauseof other methodological issues.”

     The 2001 Technology Assessment18  commissioned by the United Kingdom’s National HealthService (NHS) looked at three small studies with a total of 140 patients, and suggested that the

    potential benefit found from electrical stimulation for pressure sores be viewed with caution.

     The 2002 CMS Decision Memo19 reviewed four RCTs and a technology assessment that had beenpublished since the ECRI technology assessment in 1996, as well as other uncontrolled studies notlisted here. CMS concluded that although the clinical studies reviewed had important limitations, thelarge body of evidence as a whole is adequate to conclude that electrical stimulation is clinicallyeffective, and therefore, reasonable and necessary, for the treatment of certain chronic wounds undercertain conditions after an adequate trial of standard wound therapy.

    6

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    9/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     A 2006 Wound Healing Society guideline20 indicated a benefit to electrical stimulation for pressureulcers, basing its finding on a 1999 “meta analysis,” a 1988 RCT, a 1999 laboratory study, and an1993 RCT.

     A 2008 ICSI treatment protocol21  identified the 1994 (AHCPR) guideline 22  as its sole referenceregarding the relative benefit of electrical stimulation for pressure ulcer treatment. It concluded that

    electrical stimulation is the only adjunctive therapy with sufficient supporting evidence to warrantrecommendation for the treatment of stage III and IV pressure ulcers that have proven unresponsiveto conventional therapy.

     A 2008 BMJ systematic review 23 of electrical stimulation for pressure ulcers reviewed the 2001 NHSSR 24. It also reviewed a 2005 RCT. BMJ found that electrical stimulation, in addition to theconservative wound care, may be useful in accelerating the healing process during the first period ofcare.

     A 2008 JAMA systematic review 25  (SR) did not find benefit to electrical stimulation compared tostandard therapy for patients with pressure ulcers, when limiting its analysis to good-quality studies.

     A 2009 ECRI Institute Hotline Response26

      identified studies and listed conclusions from theirabstracts. No analysis was given.

    In summary, there is no consistent evidence of benefit for electrical stimulation therapy in thetreatment of chronic wounds. The trials available for analysis have been small and have hadmethodological limitations. While it appears to be safe, the efficacy of electrical stimulation fortreating chronic wounds is currently unknown.

    7

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    10/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Electromagnetic Therapy

     A number of summary documents have studied the use of electromagnetic therapy for patients withchronic wounds. The summary documents utilize a number of the same clinical trials for theiranalyses. A chart of these clinical trials and the summary documents that refer to them is provided

    below in Chart 2. More detailed analysis of these studies can be found in Table 2.

    Chart 2: Clinical Trials of Electromagnetic Therapy Included in Summary Documents

    Document Name   C  o  m  o  r  o  s  o  n   1   9   9   3

       I  e  r  a  n   1   9   9   0

       K  e  n   k  r  e   1   9   9   6

       T  o   d   d   1   9   9   1

       S  a   l  z   b  e  r  g   1   9   9   5

       S  t   i   l   l  e  r   1   9   9   2

    Conclusion

    Health Technology

     Assessment x x   -

    CMS Decision Memo x x x x x x   +

     JAMA SR  x x   -

    Cochrane SR - Pressure Ulcers x x   -

    Cochrane SR - Venous Ulcers x x x   -ECRI Hotline Response -

    Pressure Ulcers x x   -ECRI Hotline Response -

     Venous Ulcers x x x   -  

     The 2001 technology assessment27 commissioned by the United Kingdom’s National Health Service(NHS) found two studies of electromagnetic therapy for treatment of pressure sores to be small andof questionable validity. NHS concluded that they provided no clear evidence of a benefit ofelectromagnetic therapy on pressure sore healing.

    In its 2003 CMS Decision Memo,  28  CMS concluded that the results from electromagneticstimulation of chronic, non-healing wounds are similar to the results from electrical stimulation ofsimilar wounds, and that both are reasonable and necessary for the treatment of chronic, non-healing wounds.

     The 2008 JAMA systematic review 29  evaluated two RCTs that found improvement withelectromagnetic therapy for the treatment of pressure ulcers. One of these RCTs did not reportstatistical significance. The JAMA review concluded that there was little evidence to justify the use ofadjunctive therapies compared with standard care.

     The two 2009 Cochrane Collaboration systematic reviews on electromagnetic therapy foundinsufficient reliable information about the effects of electromagnetic therapy on both venous leg

    8

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    11/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    ulcers30 and pressure ulcers.  31  These SRs were updates of two 2002 reviews. They did not identifyany new studies.

     The 2009 ECRI Hotline Response32 listed the two 2002 SRs by the Cochrane Collaboration. ECRIdid not review any studies for its report.

    In conclusion, the same six studies have been reviewed multiple times by different researchers. Withone exception, CMS, these analyses have concluded that there is no consistently reliable evidence ofbenefit for electromagnetic therapy in the treatment of chronic wounds. The research has beencharacterized by small studies with design flaws, and should be interpreted with caution. While itappears to be safe, the efficacy of electromagnetic therapy for treating chronic wounds is currentlyunknown.

    9

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    12/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Policy Options There is currently no consensus regarding coverage policy for electrical stimulation orelectromagnetic therapy for the treatment of chronic wounds. FDA status, CMS policy and BCBS

    policy are outlined below:

    FDA

    Currently, the U.S. Food and Drug Administration (FDA) has not approved any electrical stimulationor electromagnetic devices for the treatment of chronic wounds. According to a statement from aCenters for Medicare and Medicaid Services (CMS) Decision Memo for Electrostimulation for Wounds published in 2002:33 

     The FDA has granted premarket approvals for electrical stimulators as Class III devices for theindications of bone stimulation and deep brain stimulation. FDA has also cleared electricalstimulators as Class II devices when indicated for muscle stimulation. The FDA has not cleared orapproved the use of electrical stimulation for the treatment of wounds. The FDA has concluded that

    the use of these devices for the treatment of wounds is significantly different than the use of thesedevices for the indications currently covered under a 501(k) clearance. They are considered Class IIIdevices which require the manufacturer to go through the Premarket Approval (PMA) process. Therefore, the manufacturers would have to show there is reasonable assurance of safety andeffectiveness for the treatment of wounds before the FDA could issue an approval for these devices.

     As of this time, the law prohibits manufacturers to market the use of electrical stimulators for woundhealing. Lack of approval for this particular indication, however, does not preclude physicians andother health care providers from providing this therapy, as an off-label use.

     This is the most recent FDA ruling on this topic.

    CMS

    CMS covers electrical stimulation and electromagnetic therapy as adjunctive therapies. They are onlycovered for chronic Stage III or Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venousstasis ulcers. Chronic ulcers are defined as ulcers that have not healed within 30 days of occurrence.Electrical stimulation or electromagnetic therapy will be covered only after appropriate standard wound therapy has been tried for at least 30 days and there are no measurable signs of improvedhealing. This 30-day period may begin while the wound is acute. (See Figure 4 for the full text of theCMS National Indications and Limitations of Coverage.)34 

    History of Medicare Coverage:35, 36   Coverage of Electrical Stimulation for wound healing is historically left to carrier discretion  1981: CMS bars coverage of low density electrical current for the treatment of pressure sores.

    Other forms of electrical stimulation are left to carrier discretion.  1995: CMS commissions ECRI technology assessment, sends to Technology Assessment

    Committee (TAC) for review.  1997 Based on the TAC recommendation, CMS rescinded carrier discretion and issued a national

    non-coverage policy for all forms of electrical stimulation for the treatment of chronic wounds.  1997: American Physical Therapy Association (APTA) requests a postponement of the effective

    date.  1997: CMS notifies APTA that it plans to proceed with the noncoverage implementation.

    10

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    13/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

      1997: APTA joins six individual Medicare beneficiaries and brings suit in federal district court inMassachusetts to challenge CMS’s noncoverage determination.

       The court finds that “there needs to be at least a better explanation by HCFA of its coveragedetermination, and, perhaps, a revision of that determination.”

      1998: CMS received a memo from AHRQ suggesting a tempered interpretation of the AHRQGuidelines on Treatment of Pressure Ulcers. Its recommendation to consider electrical

    stimulation for treatment was based on level B evidence from five clinical trials involving 147patients (not all receiving the treatment). “These studies were not adequately powered orpersuasive because of other methodological faults.”

      1999: APTA asked CMS to consider a national coverage policy for pulsed current and pulsedelectromagnetic induction for certain chronic wounds shown unresponsive to conventionaltherapy.

      CMS performed its own systematic review of the literature. Given inconsistencies in the qualityof the scientific literature, the issue was referred to the Medical and Surgical Procedures Panel ofthe Medicare Coverage Advisory Committee (MCAC).

      2000: MCAC voted in favor of electrical stimulation for the treatment of chronic wounds.  2001: NHS technology assessment concluded that there was a benefit for chronic wounds.  2002: CMS allows coverage for electrical stimulation of non-healing wounds, but does not cover

    any form of electromagnetic therapy for the treatment of chronic wounds.  2002: Diapulse Corporation of America formally requests reconsideration of the noncoverage

    decision for electromagnetic therapy.  2003: CMS determines that the evidence on electrostimulation therapy, while with various flaws,

    is more substantial when considered together. Electromagnetic therapy will be considered as onemodality under Electrostimulation for the treatment of chronic wounds.

    BCBS

    BlueCross BlueShield of Minnesota has found electrical stimulation and electromagnetic therapy forthe treatment of wounds to be considered investigative and not medically necessary. Claims for thisservice are subject to retrospective review and denial of coverage, as investigative services are noteligible for reimbursement. Prior authorization is not applicable, as these services are not covered.

    11

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    14/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Policy Recommendation The Health Technology Advisory Council has found electrical stimulation and electromagnetictherapy for the treatment of wounds to be considered investigative and not medically necessary.

     There is currently no consistent evidence that electrical stimulation or PEMF has benefit beyondstandard therapy for patients with chronic wounds. Claims for these services are subject toretrospective review and denial of coverage, as investigative services are not eligible forreimbursement. Prior authorization is not applicable, as these services are not covered.

     This policy will be subject to review in the event of new and compelling results from publishedrandomized clinical trials.

    12

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    15/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Proposed Codes

    All codes are not covered.

    G0281 - Electrical stimulation, (unattended), to one or more areas, for chronic Stage III and Stage IVpressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstratingmeasurable signs of healing after 30 days of conventional care, as part of a therapy plan ofcare

    G0282 - Electrical stimulation, (unattended), to one or more areas, for wound care other thandescribed in G0281.

    G0329 - Electromagnetic therapy, to one or more areas for chronic stage III and Stage IV pressureulcers, arterial ulcers, diabetic ulcers and venous stasis ulcers not demonstrating measurablesigns of healing after 30 days of conventional care as part of a therapy plan of care.

    E0769 - Electrostimulation or electromagnetic wound treatment device, not otherwise classified.

    97014 -  Application of a modality to 1 or more areas; electrical stimulation (unattended).

    13

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    16/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     Table 1: Evidence Consulted - Electrical Stimulation Organization/Title

     Year

    Method to AnalyzeEvidence

     TreatmentStudied

    PatientDiagnosis

    Conclusions

    NHS - Health Technology Assessment: Systematicreviews of wound caremanagement ( Cullum etal) 37 

    2001

    Systematic Review  

    ElectricalStimulation

    PressureUlcers

     This technology assessment was commissioned by the United Kingdom’s National HealthService (NHS): The three trials identified suggest a benefit associated with usingelectrotherapy to treat pressure sores. However, NHS notes that this suggestion is drawn fromthree small studies with a total of only 140 patients, and therefore the results should be viewed

     with caution.

    Sources:  Gentzkow (1991) 38, RCT  Griffin (1991) 39 RCT   Wood (1993) 40 RCT 

    CMS DecisionMemo41 

    2002

    Systematic Review

    ElectricalStimulation

     Wounds CMS performed a search of the literature since the 1996 ECRI technology assessment. Fourarticles and a technology assessment were found and summarized.CMS concluded thatalthough the clinical studies reviewed had important limitations, the large body of evidence asa whole is adequate to conclude that electrical stimulation is clinically effective, and therefore,

    reasonable and necessary for the treatment of the following chronic wound types undercertain conditions after an adequate trial of standard wound therapy: chronic Stage II andStage IV pressure ulcers, chronic ulcers due to arterial or venous insufficiency or diabetesmellitus. Only a small minority of chronic wounds may require additional therapies as anadjunct to standard wound therapy to heal completely.

    Sources:  Baker et al (1996) 42 RCT  Baker et al (1997) 43 RCTx  Sumano et al (1999)  44 Single arm pre-post study  Gardner et al (1999) 45  Meta-analysis  Cullum et al (200146 )47 Technology assessment

     AHCPR SupportedClinical PracticeGuidelines: Treatmentof Pressure Ulcers-Clinical Guideline 15.48  

    1994

    Guideline

    ElectricalStimulation

    PressureUlcers

    Per AHCPR: Electrical stimulation therapy may be considered for patients with Stage III orIV pressure ulcers that are refractory to more conventional treatments. Data from five clinicaltrials involving a total of 147 patients, support the effectiveness of electrotherapy in enhancingthe healing rate of pressure ulcers that have been unresponsive to conventional therapy.However, the studies in this review have been limited to a small number of research centers.

     According to AHCPR, clinicians considering electrical stimulation therapy should ensure thatthey have proper equipment and trained personnel who are following protocols shown to beeffective and safe in appropriately designed and properly conducted clinical trials.

    Sources:  Carley (1985) 49, RCT 

      Feedar (1991) 50, RCT 

      Gentzkow (1991) 51 RCT 

      Griffin (1991) 52 RCT 

      Kloth (1988) 53 RCT 

    In 1998, CMS received a memo from AHRQ suggesting a tempered interpretation of the AHRQ Guidelines on Treatment of Pressure Ulcers. Its recommendation to considerelectrical stimulation for treatment was based on level B evidence from five clinical trials

    involving 147 patients (not all receiving the treatment). “These studies were not adequatelypowered or persuasive because of other methodological faults.”

    14

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    17/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Organization/Title  Treatment Patient Conclusions Year Studied Diagnosis

    Method to AnalyzeEvidence

     Wound Repair andRegeneration:Guidelines for the

    treatment of pressureulcers (  Whitney  ) 54 

     The Wound HealingSociety

    2006

    Guideline

    ElectricalStimulation

    PressureUlcers

    Per the Wound Healing Society: Electrical stimulation may be useful in the treatment ofpressure ulcers that have not healed with conventional therapy. Improvement in the healingof chronic wounds is reported in response to electrical stimulation. The most effective type of

    electrical stimulation treatment and specific types of chronic wounds that are most likely torespond to this therapy have not been determined.

    Sources:  Gardner (1999)55 - MetaAnalysis  Kloth (1988)56 - RCT  Reger (1988) – Laboratory or animal study   Wood (1993 RCT)57 

    ICSI: Pressure Ulcer Treatment58 

    2008

     Treatment Protocol

    ElectricalStimulation

    PressureUlcers

    Per the ICSI treatment protocol: According to a 1994 Agency for Health Care Research andQuality panel, electrical stimulation is the only adjunctive therapy with sufficient supportingevidence to warrant recommendation.

    Sources:   AHCPR(1994) SR  59  

    BMJ: Pressure ulcers 60 

    2008

    Systematic Review

    ElectricalStimulation

    PressureUlcers

     According to BMJ: Compared with sham electrotherapy, it is unknown whetherelectrotherapy is more effective at 3-12 weeks at increasing healing rates of pressure ulcers.

     The results suggest that electrotherapy treatment for pressure ulcers grade 3 degree, inaddition to the conservative wound care, may be useful in accelerating the healing processduring the first period of care. Two of the RCTs in the review were suitable for meta-analysis(91 pressure ulcers), which found that electrotherapy significantly increased healing afterabout 3-5 weeks compared with sham treatment (RR 7.92, 95% CI 2.40 to 26.30). The thirdRCT (49 people) in the review had similar results after 4 weeks (% area of pressure healed:50% with electrotherapy vs. 23% with sham; P = 0.042). These RCTs were small, however,and should be interpreted with caution.

    BMJ concludes: The three trials identified suggest a benefit associated with usingelectrotherapy to treat pressure sores. However, this suggestion is drawn from three smallstudies with a total of only 140 patients, and therefore the results should be viewed withcaution.

    Sources: 

    Cullum – SR (2000)  61   Gentzkow (1991) 62   Griffin (1991)  63    Wood (1993) 64 

       Adunsky (2005) RCT 65  JAMA: Treatment ofPressure Ulcers 66  

    2008

    Systematic Review

    ElectricalStimulation

    PressureUlcers

    Per the JAMA SR: Benefit to electrical stimulation, compared to standard therapy forpatients with pressure ulcers, was not found when limiting its analysis to good-quality studies.

    Sources:   Adunsky (2005) RCT 67 

    ECRI HotlineResponse68 

    2009

    Summary of Abstracts

    ElectricalStimulation

    Chronic Wounds

    No conclusions were given.

    Sources:   Jankovic (2008)69 RCT 

     Junger (2008) 70

     RCT   Adunsky (2005) 71 RCT  Goldman (2004)72 RCT

    15

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    18/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Electrical Stimulation Studies: Comparison of Abstract and SRs

     Adunsky et al (2005) 73    Adunsky (2005) 74 This was a multicenter, double-blind, randomized, placebo-controlled study

    involving 11 departments of geriatric and rehabilitation medicine including 63 patients. We

    compared a placebo treated group (PG) with an active treatment group (TG). Treatment lastedfor 8 consecutive weeks, followed by a 12-week-period of follow-up. At day 57 (end oftreatment) and at day 147 (end of follow-up).

    o   There was no difference between the groups with regards to rates of completeclosure of ulcers (p=0.28 and 0.39, respectively), as well as for the mean timeneeded to achieve complete wound closure (p=0.16).

    o   Absolute ulcer area reduction and speed rate of wound area reduction (reflected bychange from baseline ulcer area, percentage) were better in participants allocated inthe treatment group only until day 45 (standardized estimate for trend of healingspeed -0.44 and -0.14 for TG and PG, respectively). Afterwards, there were nodifferences between the two groups.

    o   A logistic regression analysis favored complete healing in TG, compared with PG(odds ratio 1.6, CI 0.4-4.73). Analysis of per protocol patients revealed that timeneeded for wound closure was 52% longer in PG (p=0.03, compared with TG). Theresults suggest that DDCT treatment for pressure ulcers grade 3 degree, in additionto the conservative wound care, may be useful in accelerating the healing processduring the first period of care.

      BMJ (2008) 75  Repeated study abstract.   JAMA (2008)  76   Benefit to electrical stimulation, compared to standard therapy for patients with

    pressure ulcers, was not found when limiting its analysis to good-quality studies. Baker et al (1996)77   CMS (2002) 78 80 patients with spinal cord injuries were randomly assigned to one of three

    stimulation groups: group A received asymmetric, biphasic stimulation, group B receivedsymmetric, biphasic stimulation, and group MC received microcurrent stimulation. The controlgroup received the same stimulation procedures but no electrical current was applied. The

    authors stated that “no statistical differences were found in initial or discharge ulcer areas or inthe mean healing rates among the four treatment groups.” The number of patients that withdrew from the study was not reported. Intention-to-treat analysis was not used. The resultsof multivariate analyses to adjust for confounding variables were not presented.

    Baker et al (1997)79   CMS (2002) 80 80 patients with spinal cord injuries were randomly assigned to one of three

    stimulation groups: group A received asymmetric, biphasic stimulation, group B receivedsymmetric, biphasic stimulation, and group MC received microcurrent stimulation. The controlgroup received the same stimulation procedures but no electrical current was applied. Theauthors stated that the mean healing rates among the four groups were not significantly different. The number of patients that withdrew from the study was not reported. Intention-to-treatanalysis was not used. The results of multivariate analyses to adjust for confounding variables

     were not presented.Carley et al(1985) 81,   Carley (1985) 82  Thirty patients with indolent ulcers located either below the knee or in the sacral

    area were randomly assigned to the low density direct current (LIDC) protocol or to moreconventional wound therapy. The patients in each treatment group were matched by age,diagnosis, wound size, and wound etiology. Comparison revealed 1.5 to 2.5 times faster healingin those receiving LIDC, which was statistically significant. The wounds treated with LIDCrequired less debridement and the healed scars were more resilient. Additionally, no woundinfections occurred and patients reported less discomfort at the wound site. Low intensity direct

    16

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    19/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    current appears to be a convenient, reproducible, and effective method for improved healing ofchronic open wounds and warrants more widespread use in the clinical setting.

    Feedar et al (1991)  83   Feedar (1991) 84  The purposes of this randomized, double-blind, multi-center study were to

    compare healing of chronic dermal ulcers treated with pulsed electrical stimulation with healingof similar wounds treated with sham electrical stimulation and to evaluate patient tolerance to the

    therapeutic protocol. Forty-seven patients, aged 29 to 91 years, with 50 stage II, III, and IVulcers were randomly assigned to either a treatment group (n = 26) or a control (sham treatment)group (n = 24). Treated wounds received 30 minutes of pulsed cathodal electrical stimulationtwice daily at a pulse frequency of 128 pulses per second (pps) and a peak amplitude of 29.2 mAif the wound contained necrotic tissue or any drainage that was not serosanguinous. A saline-moistened non-treatment electrode was applied 30.5 cm (12 in) cephalad from the wound. Thisprotocol was continued for 3 days after the wound was debrided or exhibited serosanguinousdrainage. Thereafter, the polarity of the treatment electrode on the wound was changed every 3days until the wound progressed to a stage II classification. The pulse frequency was thenreduced to 64 pps, and the treatment electrode polarity was changed daily until the wound washealed. Patients in the control group were treated with the same protocol, except they receivedsham electrical stimulation. After 4 weeks, wounds in the treatment and control groups were

    44% and 67% of their initial size, respectively. The healing rates per week for the treatment andcontrol groups were 14% and 8.25%, respectively. The results of this study indicate that pulsedelectrical stimulation has a beneficial effect on healing stage II, III, and IV chronic dermal ulcers.

    Gardner et al (1999) 85   Gardner (1999) 86  Fifteen studies, which included 24 electrical stimulation samples and 15

    control samples, were analyzed. Although electrical stimulation produces a substantialimprovement in the healing of chronic wounds, further research is needed to identify whichelectrical stimulation devices are most effective and which wounds respond best to this

    sented.ty (2006) 88  referenced this article.

    d

    (p = 0.042). The baseline ulcer areas given demonstrated larger ulcersup.

    ients (N not reported in abstract) were treated for 14 weeks with either active

    py group compared withtrol group (RR = 1.69; 95% CI, 0.37 to 7.67).

    tudy.

    treatment.  CMS (2002) 87  The results in the study abstract were pre   Wound Healing Socie

    Gentzkow et al (1991) 89   NHS (2001)  90  This study randomized patients with stage 2, 3 or 4 pressure ulcers to receive

    either electrical stimulation twice daily for 4 weeks or sham stimulation. Both groups receivestandard treatment of cleaning with normal saline, a wound dressing, and turning to relievepressure on the affected area. After 4 weeks there was a mean percentage area of ulcer healed of49.8% (SD = 30.9) in the electro-therapy group and a 23.4% (SD = 47.4) mean percentage ulcerhealing in the sham groupin the intervention gro

    Goldman et al (2004) 91   Goldman (2004)  92 The results of this study demonstrate that HVPC decreased the area of

    ischemic wounds, reversing the expected increase in wound size, and improved microcirculation.  ECRI (2009) 93  Pat

    or sham therapy.Griffin et al (1991)94  

    NHS (2001)  95 This study examined only 17 male patients with spinal cord injury and a pressuresore. Participants were randomized to receive electrotherapy plus standard treatment or shamtherapy plus standard treatment. The standard treatment consisted of wound cleansing anddressing. This this trial, 3/8 (37.5%) ulcers healed in the electrothera2/9 (22%) in the con

     Jankovic et al (2008) 96    Jankovic (2008) 97  Thirty-five patients with 43 chronic painful leg ulcers participated in the s

     The subjects were separated into two random groups, one treated with frequency rhythmicelectrical modulation system (FREMS) and the control group. Comparing the findings of

    17

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    20/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    decrease leg ulcer surface, pain, leg ulcer score, score of vicinity (statistically significant at thelevel P < 0.05) with the controls, it was established that FREMS system accelerated ulcer healing,reduced pain and demonstrated better effects compared to the control group. The results of thestudy indic

     

    ate that FREMS therapy accelerates wound closure and depresses the pain of chronic

    ion from Serbia

    al stimulation seems to be a viable treatment option for therapy-resistant venous leg

    as done in Germany  

    lcers,

    e

    in

     voltage stimulation accelerates the healing rate of stage IVhuman subjects. 

    p had

     were larger in the baseline in the intervention group, this result is againstthe direction of bias.

    leg ulcers.   This is an e-publicat

     Junger et al (2008)98    Junger (2008) 99  We investigated 39 patients in a prospective, placebo-controlled, double blind

    study on the effect of low-frequency pulsed current (Dermapulse) on healing in chronic venousulcers during a 4-month course of treatment. All patients had chronic venous ulcers. In verumgroup 3 ulcers healed and ulcer area was reduced significantly. In placebo group 2 ulcers healed.Ulcer size was reduced significantly in each group (paired test), the difference of ulcer areareduction between the "verum" and the placebo group (unpaired test) was not significant.Electriculcers. 

       This study w Kloth (1988) 100    The purpose of this study was to determine whether high voltage electrical stimulation

    accelerates the rate of healing of dermal ulcers. Sixteen patients with stage IV decubitis uranging in age from 20 to 89 years, participated in the study. The patients were assignedrandomly to either a Treatment Group (n = 9) or a Control Group (n = 7). Patients in the Treatment Group received daily electrical stimulation from a commercial high voltage generator.Patients in the Control Group had the electrodes applied daily but received no stimulation. Thulcers of patients in the Treatment Group healed at a mean rate of 44.8% a week and healed100% over a mean period of 7.3 weeks. The ulcers of patients in the Control Group increasedarea an average of 11.6% a week and increased 28.9% over a mean period of 7.4 weeks. Theresults of this study suggest that highdecubitis ulcers in

     Wood et al (1993)101   NHS (2001)  102 This study compared electrotherapy with sham therapy for the treatment of

    chronic pressure ulcers. Both groups received standard treatment of wound cleansing, moistdressing and whirlpool baths. After 8 weeks, 25/43 (58%) ulcers in the electrotherapy grouhealed, compared with 1/31 (3%) in the sham therapy group (RR = 18.02; 95% CI, 2.58 –126.01). As the ulcers

      18

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    21/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

     Table 2: Evidence Consulted - Electromagnetic Therapy Organization/Title

     Year

    Method to AnalyzeEvidence

     TreatmentStudied

    PatientDiagnosis

    Conclusions

    NHS: Health Technology Assessment: Systematicreviews of wound caremanagement 103 

    2001

    Systematic Review  

    Electro-magnetic Therapy

    PressureUlcers  This technology assessment was commissioned by the United Kingdom’s National HealthService (NHS): Two studies of the use of electromagnetic therapy for the treatment ofpressure sores were included for the review. These two studies were small and of questionable

     validity, and therefore they provide no clear evidence of a benefit of electromagnetic therapyon pressure sore healing.

    Sources:  Comorosan 1993104 RCT  Salzberg 1995105  RCT

    CMS Decision Memo

    2003

    Systematic Review

    Electro-magnetic

     Therapy

    PressureUlcers

    CMS performed a search of the literature since the 1996 ECRI technology assessment. Fourcontrolled studies and a technology assessment were found and summarized. Additionaluncontrolled studies were studied but are not listed below. CMS concluded that although theclinical studies reviewed had important limitations, the large body of evidence as a whole isadequate to conclude that electrical stimulation is clinically effective, and therefore, reasonableand necessary for the treatment of the following chronic wound types under certainconditions after an adequate trial of standard wound therapy: chronic Stage II and Stage IV

    pressure ulcers, chronic ulcers due to arterial or venous insufficiency or diabetes mellitus.Only a small minority of chronic wounds may require additional therapies as an adjunct tostandard wound therapy to heal completely.

    Sources:  NHS Health Technology Assessment (2001) SR

    o  Comorosan 1993106  RCTo  Salzberg 1995107  RCT

      Ieran 1993108 RCT   Todd 1991109 non-randomizedCT  Stiller 1992110   Kenkre 1996111 RCT

     JAMA: Treatment ofPressure Ulcers 112  

    2008

    Systematic Review

    Electro-magnetic

     Therapy

    PressureUlcers

    Per JAMA: Twenty-one RCTs (987 participants) evaluated adjunctive therapies. Among thegood-quality RCTs examining adjunctive therapies, there were no benefits to theinterventions, which included electric current (vs. placebo electric current), laser (vs. moistsaline gauze), and ultrasound (vs. placebo ultrasound).

    In the JAMA review, two RCTs examined electromagnetic therapy and found improvementsin wound healing compared with placebo or standard care, but one of these RCTs did notreport statistical significance.

    Sources:  Comorosan 1993 RCT:113   Salzberg CA 1995 RCT: 114 

    ECRI HotlineResponse 

    2009

    Summary of Abstracts

    Electro-magnetic

     Therapy

     VenousLeg Ulcers

    No conclusions were given by ECRI.  Cochrane Collaboration - Ravaghi (2006) SR This update identified no new trials. A

    total of three eligible RCTs were identified by the original review. Two trials comparedthe use of electromagnetic therapy with sham therapy and one trial compared it withstandard topical treatments. One trial found a difference in healing rates of borderlinestatistical significance between electromagnetic therapy and sham therapy, although thedirection of treatment effect was consistently in favour of electromagnetic therapy, thedifference was not statistically significant. There is currently no reliable evidence of

    benefit of electromagnetic therapy in the healing of venous leg ulcers.

    Sources:  Ieran 1990 RCT115   Kenkre 1996 RCT116   Stiller 1992 RCT117 

    19

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    22/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Organization/Title  Treatment Patient Conclusions Year Studied Diagnosis

    Method to AnalyzeEvidenceECRI HotlineResponse

    2009

    Summary of Abstracts 

    Electro-magnetic

     Therapy

    PressureUlcers

    No conclusions were given by ECRI.  Cochrane Collaboration - Olyaee (2006) - SR Only 2 RCTs met the inclusion criteria.

    Studies examined a total of 60 patients with grade II or III pressure ulcers. Neither

    study found a statistically significant difference between the healing rates of peopletreated with electromagnetic therapy compared with the control groups. The resultsprovide no evidence of benefit in using electromagnetic therapy to treat pressure ulcers.

    Sources:  Comorosan 1993118  RCT:  Salzberg CA 1995119  RCT:

     The CochraneCollaboration:

     Electromagnetic therapy for treating venous legulcers.120 

    2009

    Systematic Review

    Electro-magnetic

     Therapy

     VenousLeg Ulcers

    Cochrane Collaboration (2009 Update): Only three very small RCTs have been undertaken toassess the effect of electromagnetic therapy on the healing of venous leg ulcers. None ofthese studies has the statistical power to detect any statistically significant clinical differences.Furthermore, the one trial that found a borderline statistical significance in favor ofelectromagnetic therapy was biased in favor of electromagnetic therapy, as baselinemeasurements showed that the control group ulcers were larger than those in the treatmentgroup at the start of the trial. It is worth noting that the healing rates in the control group ofall the studies, and in particular those of Ieran 1990 and Stiller 1992 were poor. Together, thethree trials do not provide sufficient reliable information about the effects of electromagnetictherapy on venous ulcers, and further research is required.

    Sources:  Ieran 1990121 RCT  Kenkre 1996122 RCT  Stiller 1992123 RCT

     The CochraneCollaboration:

     Electromagnetic therapy for treating pressureulcers.124 

    2009

    Systematic Review

    Electro-magnetic

     Therapy

    PressureUlcers

    Cochrane Collaboration (2009 Update): Two RCTs were identified for inclusion (total of 60participants). While the results of both these small trials suggest that electromagnetic therapyis of benefit in the healing of pressure ulcers, neither trial reaches statistical significance and,consequently, the evidence is unreliable. Both trials contained small numbers of patients, andused different regimens of treatment over different time scales. The trials, particularlyComorosan 1993, did not report severity of pressure ulcers and baseline comparisonsadequately. Consequently, the results should be viewed as unreliable until further researchinvolving larger numbers of patients that can be considered alongside these trials, becomesavailable.

    Sources:  Comorosan 1993125  RCT:  Salzberg CA 1995126  RCT:

    Electrical Stimulation Studies: Comparison of Abstract and SRs

    Comoroson (1993) 127   Comoroson (1993) This was a three-armed study comparing electromagnetic therapy in

    combination with standard therapy, and with standard therapy alone, on 17 female and 13 malepatients with grade II and III pressure ulcers. Results show that 17 out of 20 (85%) ulcers healedin the electromagnetic therapy group within two weeks compared with no ulcers healing in eitherof the other two groups (five ulcers in each); the relative risk (RR) was 10.00 (95%confidenceinterval (CI) 0.70 to 143.06).

      Cochrane Collaboration (2009) The study did not provide information about the strategies usedfor randomization, so it is not known why the three arms in the study contain an unevendistribution of patients. The trial also did not report the severity of pressure ulcers and baselinecomparisons adequately. Consequently, the results should be viewed as unreliable.

      NHS (2001) This trial was extremely small, and the process of randomization was not described,despite the unequal distribution between groups.

    20

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    23/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

      CMS (2003) This was a case-controlled study of 30 hospitalized, terminally ill patients. All 20patients in the active treatment group showed very good to excellent results based on asubjective rating of the extent of healing (75% or better healing). No patients in either controlgroup showed very good to excellent results. Duration of treatments varied. No statistical tests were performed. The selection and matching of cases and controls was also not performed.

    Ieran et al (1990)  Ieran (1990) Three people in the control group (14%) and four in the experimental one (18%)

     were lost to follow up and thus excluded from the analysis. Therefore, 19 people in the controlgroup and 18 in the experimental group were included in the analysis. In the electromagnetictherapy group at 90 days, twelve out of 18 (67%) ulcers had healed, compared with six out of 19(32%) in the sham therapy group: the relative risk (RR) was 2.11 (95% confidence interval (CI)1.01 to 4.42) However, the control group ulcers were larger at baseline (thus biasing the trial infavor of the electromagnetic therapy group). Moreover, if the people lost to follow up wereregarded as treatment failures, the difference would not be statistically significant: RR 2.0 (95%CI 0.92 to 4.37).

      CMS (2003) This study contained design and methodological flaws such as a small sample sizeand a high rate of patient exclusions. In addition, multivariate analyses to adjust for differences

    in baseline ulcer sizes between groups were not reported. Baseline ulcer size is important sincelarger ulcers tend to heal slower than smaller ulcers.

    Kenkre et al (1996)  Kenkre (1996) At 50 days, when the two electrotherapy treatment arms were grouped together,

    two out of 10 (20%) venous ulcers were healed in the electromagnetic therapy group, compared with two out of nine (22%) in the sham electromagnetic therapy group: the RR was 0.90 (95% CI0.16 to 5.13) after a 50 day period. 

      CMS (2003) 19 patients were randomized to one of 2 active therapies (10) or placebo treatment(9). Multivariate analyses to control for confounding variables, such as ulcer size and chronicity,at baseline were not reported. The numbers of patients completely healed were similar in all 3test groups at the day 50 endpoint.

    Salzberg et al (1995)   This study compared electromagnetic therapy with sham therapy in 30 male participants with a

    spinal cord injury and a grade II or grade III pressure ulcer. at 12 weeks, three out of five (60%)grade III pressure ulcers in the electromagnetic therapy group had healed, compared with noneout of five in the sham electrotherapy group: RR was 7.00 (95% CI 0.45 to 108.26). In theelectromagnetic therapy group, the ulcer area decreased by an average of 70.6%, whereas in thecontrol group the ulcer area decreased by an average of 20.7% A median of 84% healing ofgrade II pressure ulcers in the electromagnetic therapy group at one week compared with 40% inthe sham therapy group (P value 0.01). The median for days to complete healing was 13 days forthe treatment group, compared with 31.5 days for the control group (P value < 0.001). There was no statistically significant difference in the baseline median area of ulcers between sham andelectromagnetic therapy groups.

     

    CMS (2003) Of the 5 pressure ulcers greater than 60 cm2, only 1 was in the active group. Forhealing rates, baseline wound size is an important factor. Of the 10 patients with stage III ulcers,no statistically significant differences were reported. All stage II ulcers in both groups healed bythe week 12 endpoint so there was no difference in the critical outcome of complete woundhealing.

      NHS (2001) As the stage II pressure sores were significantly smaller at baseline in theelectrotherapy group than in the sham group, this result goes with the direction of bias, as theoutcome (percentage healing) favors smaller ulcers. For stage III pressure sores, 3/5 soreshealed in the electromagnetic therapy group compared to none in the sham therapy group.

    21

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    24/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    Stiller et al (1992)128   Stiller (1992)  129  A prospective, randomized, double-blind, placebo-controlled multi-centre study

    assessed the clinical efficacy and safety of pulsed electromagnetic limb ulcer therapy (PELUT) inthe healing of recalcitrant, predominantly venous leg ulcers. The portable device was used athome for 3 h daily during this 8-week clinical trial as an adjunct to a wound dressing. Wound

    surface area, ulcer depth and pain intensity were assessed at weeks 0, 4 and 8. At week 8 theactive group had a 47.7% decrease in wound surface area vs. a 42.3% increase for placebo (P <0.0002). Investigators' global evaluations indicated that 50% of the ulcers in the active grouphealed or markedly improved vs. 0% in the placebo group, and 0% of the active group worsened vs. 54% of the placebo group (P < 0.001). Significant decreases in wound depth (P < 0.04) andpain intensity (P < 0.04) favouring the active group were seen. Patients whose ulcers improvedsignificantly after 8 weeks were permitted to continue double-blind therapy for an additional 4 weeks. Eleven active and one placebo patient continued therapy until week 12, with the activetreatment group continuing to show improvement. There were no reports of adverse eventsattributable to this device. We conclude that the PELUT device is a safe and effective adjunct tonon-surgical therapy for recalcitrant venous leg ulcers.

      CMS (2003) 31 patients with an ulcer of at least 2 weeks were studied. Active treatment

    consisted of unsupervised, home-administered pulsed electromagnetic limb ulcer therapy. Todd et al (1991)130   CMS (2003)  131 This study of 19 patients with venous ulcers were assigned (not randomly) to

    standard therapy with either active or inactive PEMF. At 5 weeks, no statistically relevantdifferences were found in healing rates of ulcers.

    22

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    25/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    23

     

    References

    1 H.F. No 3617, As Introduced – 85th Legislative Session (2008-2009) LINK  2 S.F. No 9961, As Introduced – 86th Legislative Session (2008-2009)3 S.F. No 688, 1st Engrossment – 86th Legislative Session (2009-2010) LINK  4 ECRI - Electrical Stimulation and EM Therapy for Chronic Wounds, 20075 ECRI Electrical Stimulation and EM Therapy for Chronic Wounds, 20076 Whitney J, Phillips L, Aslam R, et al. Guidelines for the treatment of pressure ulcers. Wound Rep Reg.  2006;14:663-79.LINK  7 ECRI Guideline for Pressure Ulcers, 20078 AHCPR Supported Clinical Practice Guidelines. Treatment of Pressure Ulcers. Clinical Guideline Number 15; AHCPR  Publication No. 95-0652. LINK  9 Simon DA, Dix FP, McCollum CN. Management of venous leg ulcers. BMJ  2004;328:1358-62.10 Reddy M, Gill SS, Kalkar SR et al. Treatment of Pressure Ulcers: A Systematic Review JAMA. 2008;300(22):2647-2662.LINK  11 ECRI Guideline for Pressure Ulcers, 200712 CMS Technology Assessment (ECRI): Electrical Stimulation for the Treatment of Chronic Wounds, 1996, rev. 1997. Pg.221. LINK  13 ECRI Guideline for Pressure Ulcers, 200714 CMS Technology Assessment (ECRI): Electrical Stimulation for the Treatment of Chronic Wounds, 1996, rev. 1997. Pg.221. LINK  15 Ravaghi H, Flemming K, Cullum NA, Manesh AO. Electromagnetic therapy for treating venous leg ulcers. The CochraneCollaboration   - 2006 LINK TO ABSTRACT 16 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068N).7/3/2002. LINK  17 AHCPR Supported Clinical Practice Guidelines. Treatment of Pressure Ulcers. Clinical Guideline Number 15; AHCPRPublication No. 95-0652. LINK  18 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7)laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess 2001;5:1–221. LINK  19 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068N).7/3/2002. LINK  20 Whitney J, Phillips L, Aslam R, et al. Guidelines for the treatment of pressure ulcers. Wound Repair & Regeneration  [serialonline]. November 2006;14(6):663-79. Available from: CINAHL Plus with Full Text, Ipswich, MA. LINK  21 Institute for Clinical Systems Improvement (ICSI). Health Care Protocol: Pressure Ulcer Treatment. First Edition

     January 2008. LINK  22 AHCPR Supported Clinical Practice Guidelines. Treatment of Pressure Ulcers. Clinical Guideline Number 15; AHCPR  Publication No. 95-0652. LINK  23 Cullum N, Petherick E. Pressure Ulcers. BMJ Clinical Evidence. 2008; 03:1901. LINK TO WEBSITE 24 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7)laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess. 2001;5:1–221.25 Reddy M, Gill SS, Kalkar SR et al. Treatment of Pressure Ulcers: A Systematic Review JAMA. 2008;300(22):2647-62.LINK  26 ECRI Institute. Hotline Response: Electrical Stimulation and Electromagnetic Therapy for the Treatment of Chronic

     Wounds. 2009.27 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7)laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess. 2001;5:1–221. LINK  28 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068R).12/17/2003. LINK  29 Reddy M, Gill SS, Kalkar SR, et al. Treatment of Pressure Ulcers: A Systematic Review.  JAMA. 2008;300(22):2647-62.

    30 Ravaghi H, Flemming K, Cullum NA, et al. Electromagnetic therapy for treating venous leg ulcers. The CochraneCollaboration   - 2006 LINK TO ABSTRACT 31 Manesh AO, Flemming K, Cullum NA, et al. Electromagnetic therapy for treating pressure ulcers. The CochraneCollaboration  - 2006 LINK TO ABSTRACT 32 ECRI Institute. Hotline Response: Electrical Stimulation and Electromagnetic Therapy for the Treatment of Chronic

     Wounds.2009.33 Centers for Medicare and Medicaid Services: Decision Memo for Electrostimulation for Wounds (CAG-00068N).LINK  34 Centers for Medicare and Medicaid Services: National Coverage Determination. NCD for Electrical Stimulation (ES)and Electromagnetic Therapy for the Treatment of Wounds (270.1). (Effective 07/01/2004.) LINK  

    https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=H3617.0.html&session=ls85https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=H3617.0.html&session=ls85https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86http://tc.liblink.umn.edu/sfx_local?sid=Entrez:PubMed&id=pmid:17199832http://tc.liblink.umn.edu/sfx_local?sid=Entrez:PubMed&id=pmid:17199832http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=270.1&ncd_version=3&basket=ncd%3A270%2E1%3A3%3AElectrical+Stimulation+%28ES%29+and+Electromagnetic+Therapy+for+the+Treatment+of+Woundshttp://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=270.1&ncd_version=3&basket=ncd%3A270%2E1%3A3%3AElectrical+Stimulation+%28ES%29+and+Electromagnetic+Therapy+for+the+Treatment+of+Woundshttp://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=270.1&ncd_version=3&basket=ncd%3A270%2E1%3A3%3AElectrical+Stimulation+%28ES%29+and+Electromagnetic+Therapy+for+the+Treatment+of+Woundshttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/http://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.thecochranelibrary.com/http://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://www.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=13&http://jama.ama-assn.org/cgi/content/full/300/22/2647?eafhttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://tc.liblink.umn.edu/sfx_local?sid=Entrez:PubMed&id=pmid:17199832https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=S0688.1.html&session=ls86https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=H3617.0.html&session=ls85

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    26/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    35 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068N).7/3/2002. LINK  36 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068R).12/17/2003. LINK  37 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management:P (5) beds; (6) compression;(7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technology Assessment. 2001;

    5(0):1-221. LINK  38 Gentzkow GD, Pollack SV, Kloth LC, et al. . Improved healing of pressure ulcers using dermapulse, a new electricalstimulation device. Wounds. 1991;Sep-Oct;3(5):158-70.39 Griffin JW, Tooms RE, Mendius RA, et al . Efficacy of high voltage pulsed current for healing of pressure ulcers inpatients with spinal cord injury. Phys Ther. 1991;Jun;71(6):433-42.40 Wood JM, Evans PE III, Schallreuter KU, et al. A multicenter study on the use of pulsed low-intensity direct current forhealing chronic stage II and stage III decubitus ulcers. Arch Dermatol. 1993;129:999–1009. LINK TO ABSTRACT 41 Centers for Medicare and Medicaid Services. Decision Memo for Electrical Stimulation for Wounds (CAG-00068N).7/3/2002. LINK  42 Baker LL, Ryabi S, Villar F, et al. Effect of electrical stimulation waveform on healing of ulcers in human beings withspinal cord injury. Wound Rep Reg. 1996 Jan-Mar; 4(1):21-8.43 Baker LL, Chambers R, DeMuth SK, et al. Effects of electrical stimulation on wound healing in patients with diabeticulcers. Diabetes Care. 1997; 20(3):405-12.44 Sumano H, Mateo G. The use of acupuncture-like electrical stimulation for wound healing of lesions unresponsive toconventional treatment. Am J Acupunct. 1999; 27(1-2):5-14.45

     Gardner SE, Frantz RA, Schmidt FL. Effect of electrical stimulation on chronic wound healing: a meta-analysis. WoundRep Reg. 1999;7:495–503. LINK TO ABSTRACT 46 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management:P (5) beds; (6) compression;(7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technology Assessment. 2001;5(0):1-221. LINK  47 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management:P (5) beds; (6) compression;(7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technology Assessment. 2001;5(0):1-221. LINK  48 AHCPR Supported Clinical Practice Guidelines. Treatment of Pressure Ulcers. Clinical Guideline Number 15; AHCPRPublication No. 95-0652. LINK  49 Carley PJ, Wainapel SF. . Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys MedRehabil. 1985 Jul;66(7):443-6.50 Feedar JA, Kloth LC, Gentzkow GD. Chronic dermal ulcer healing enhanced with monophasic pulsed electricalstimulation. Phys Ther. 1991 Sep;71(9):639-49.51 Gentzkow GD, Pollack SV, Kloth LC, et al. Improved healing of pressure ulcers using dermapulse, a new electrical

    stimulation device. Wounds  1991 Sep-Oct;3(5):158-70.52 Griffin JW, Tooms RE, Mendius RA, et al. Efficacy of high voltage pulsed current for healing of pressure ulcers inpatients with spinal cord injury. Phys Ther. 1991 Jun;71(6):433-42.53 Kloth LC, Feedar JA. Acceleration of wound healing with high voltage, monophasic, pulsed current. Phys Ther. 1988

     Apr;68(4):503-8. [See Erratum in: Phys Ther. 1989 Aug;69(8):702.]54 Whitney J, Phillips L, Aslam R, et al. Guidelines for the treatment of pressure ulcers. Wound Repair & Regeneration. November 2006;14(6):663-79. LINK  55 Gardner SE, Frantz RA, Schmidt FL. Effect of electrical stimulation on chronic wound healing: a meta-analysis. WoundRep Reg. 1999;7:495–503. LINK TO ABSTRACT 56 Kloth LC, Feedar JA. Acceleration of wound healing with high voltage, monophasic, pulsed current. Phys Ther . 1988

     Apr;68(4):503-8. [See Erratum in: Phys Ther. 1989 Aug;69(8):702.]57 Wood JM, Evans PE III, Schallreuter KU, et al. A multicenter study on the use of pulsed low-intensity direct current forhealing chronic stage II and stage III decubitus ulcers. Arch Dermatol. 1993; 129: 999–1009. LINK TO ABSTRACT 58 Institute for Clinical Systems Improvement (ICSI). Health Care Protocol: Pressure Ulcer Treatment. First Edition

     January 2008. LINK  59 AHCPR Supported Clinical Practice Guidelines. Treatment of Pressure Ulcers. Clinical Guideline Number 15; AHCPRPublication No. 95-0652. LINK  60 Cullum N, Petherick E. Pressure Ulcers. BMJ Clinical Evidence. 2008; 03:1901. LINK TO WEBSITE 61 Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7)laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess. 2001;5:1–221. LINK  62 Gentzkow GD, Pollack SV, Kloth LC, et al. Improved healing of pressure ulcers using dermapulse, a new electricalstimulation device. Wounds. 1991 Sep-Oct;3(5):158-70.63 Griffin JW, Tooms RE, Mendius RA, et al. Efficacy of high voltage pulsed current for healing of pressure ulcers inpatients with spinal cord injury. Phys Ther. 1991 Jun;71(6):433-42.64 Wood JM, Evans PE III, Schallreuter KU, et al. A multicenter study on the use of pulsed low-intensity direct current forhealing chronic stage II and stage III decubitus ulcers. Arch Dermatol. 1993;129:999–1009. LINK TO ABSTRACT 

    24

    http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://clinicalevidence.bmj.com/ceweb/about/index.jsphttp:/clinicalevidence.bmj.com/ceweb/about/index.jsphttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp:/www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.htmlhttp://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://search.ebscohost.com.floyd.lib.umn.edu/login.aspx?direct=true&db=rzh&AN=2009481432&site=ehost-livehttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.5124http://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/10633009?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&http://www.ncbi.nlm.nih.gov/pubmed/8352625?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.ncbi.nlm.nih.gov/pubmed/11368833?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSumhttp://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=28&basket=http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=27&

  • 8/19/2019 Adjunctive Terapi for Chronic Wound

    27/167

    HSAC Evidence Summary

    Adjunctive Therapies for Chronic Wounds

    65 Adunsky A, Ohry A. Decubitus direct current treatment (DDCT) of pressure ulcers: results of a randomized double-blinded placebo controlled study. Arch Gerentol Geriatr. 2005;41:261-69. LINK TO ABSTRAC