The Efficacy of a New Two-Layer Unna Boot System* in the Treatment of Lower Extremity Wounds and EdemaEric J. Lullove, DPM, CWS FACCWS Boca Raton, FL

Khaled El-Tahlawy, Ph.D., Salisbury, MA

RESULTSABSTRACT

REFERENCES

*CoFlex™ is a registered trademark of Andover Healthcare Inc. For more information about

CoFlex™ UB-Z or Coflex™ UB-C, call 800-482-6686 or visit www.andoverhealthcare.com.

CONCLUSIONS

This evaluation trial study of a new Unna Boot Multilayer compression system for the

management of venous insufficiency edema and lymphedema with or without wounds

demonstrates the initial effectiveness of this treatment modality as a first line therapy

in the outpatient setting. In all results, the data demonstrated excellent user-friendly

application and patient compliance. In treatment of over 100 patients, this study

shows the strong clinical efficacy of this new modality to effectively treat this difficult

group of patients encountered in the healthcare setting. The increased level of

patient compliance also demonstrates that this treatment line can reduce the

recurrence of venous ulcerations of the lower leg with better clinical outcomes using

this new technology.

1. Trent JT, et al. “Venous ulcers: pathophysiology and treatment options.” Ostomy Wound Management. May 2005, Vol. 51(5), pages 38–54.

2. Felty CL and Rooke TW. “Compression therapy for chronic venous insufficiency.” Seminars in Vascular Surgery. March 2005, Vol. 18(1), pages 36-40.

3. Seaman S. “Dressing selection in chronic wound management.” Journal of the American Podiatric Medical Association. Jan 2002, Vol. 92(1), pages 24-33.

4. Young JR. “The swollen leg. Clinical significance and differential diagnosis.” Cardiology Clinics. Aug 1991, Vol. 9(3), pages 443-56.

5. Miller S. “Compression Therapy for Foot Wounds: Overview and Case Reports.” Wounds. Oct 2005, Vol. 17(10), pages 278-281.

MATERIALS AND METHODS

The effective use of compression therapy in the treatment of wounds

and skin irritations of the lower extremities, as well as venous stasis

ulcers, is widely accepted as evidenced by the pervasive application of

wraps, bandages, and stockings by wound care professionals.

Podiatrists, hospitals, wound care clinics and long-term care providers

rely on compression therapy to treat lower extremity afflictions, ease

edema, heal wounds and aid in the comfort of patients. However, the

technology of compression therapy has not changed for decades.

Doctors and clinicians in the practice of using compression therapy to

treat patients for afflictions of the lower extremity, including venous

stasis ulcers, pressure ulcers, diabetic foot ulcers, edema, chronic and

traumatic wounds, burns, rashes, sprains, strains and skin tears, are

severely limited by the availability of diverse, cost effective, and

convenient treatment options. Although the existing technology is

somewhat consistent in its rate of success, the field of products

available to doctors and clinicians is limited in design.

The new Unna boot consists of a two-layers medicated bandage

system, including an inner layer comprising a foam material, and an

outer layer comprising a separate short stretch (40 %) compression

bandage. The foam layer is impregnated with a zinc oxide based

formulation containing water, calamine, glycerin, zinc oxide, gelatin,

sorbitol, magnesium aluminum silicate, sodium bicarbonate and

Paraben-DU. Approximately 258 treatments using the new Unna boot

have been applied to patients.

Early results, shown through an evaluation form completed for each

patient treated, report that doctors, clinicians and patients are

overwhelmingly pleased with the new Unna boot. This poster study will

demonstrate these positive results and evidence of a new product

indicated for treatment of lower extremity wounds and edema.

Clinical product evaluation trials were conducted over a period of

4 months from October 2011 through January 2012 at various

medical facilities around the continental United States. In all, a

total of 6 (six) centers were involved in the product trials. 105

patients were included between the six centers totaling 258

treatment applications. The goal of this study was to show

efficacy of a new Unna boot multilayer compression bandage in

the treatment of lower extremity edema.

Inclusion criteria included any patient with lower extremity edema,

with or without wounds that were not clinically infected. Patients

with histories of extensive low ejection fraction and/or severe CHF

were eliminated from the product trial evaluations. Patients were

all ambulatory and none were residents or currently in treatment

of any inpatient skilled or hospital unit.

Products were clinically-rated at the time of application along with

specific patient-driven answers at each application. 14 specific

resultant categories were obtained based on the application of the

product clinically.

Evaluation forms documenting each visit were filled out and

completed by the treating specialist and were recorded and

electronically or faxed to the author(s) for data analysis.

0

10

20

30

40

50

60

70

80

90

100

Patients Treatments

Cox Health

Concord

QOTV WCC

RIDC

Dr.Lullove

SLU

Table 1: Unna Boot Clinical Trial Breakdown By Location

Table 2: Unna Boot Clinical Evaluation Results All Locations

The Authors would like to acknowledge the following centers for their participation:

St. Louis University Department of Surgery, St. Louis, MO

CoxHealth Wound Care Center, St. Louis, MO

Concord Hospital Wound Center, Concord, NH

Regional Infectious Disease Center, Lima, OH

Queen of the Valley Wound Care Center, Napa, CA

Dr. Eric J. Lullove, DPM PA, Boca Raton, FL

Results based on 258 clinical evaluation applications

Foam Application

Short Stretch Self Adherent

Application

Finished Application