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COMPARATIVE STUDY OF THE CLINICAL OUTCOME OF THREE TYPES OF DRESSINGS IN THE MANAGEMENT OF DIABETIC FOOT ULCERS

Dr. Nafees Javed QureshiDr. M S Sridhar1Introduction Diabetic Foot Ulcers (DFU) common complication.India leads the world with 40.9 million population with diabetes.Foot ulcers are single most important risk factor for non-traumatic amputations.Diabetic foot ulcers need standard care with multi-disciplinary approach.

OBJECTIVES To compare the clinical outcome of three types of dressings in the management of diabetic foot ulcers.- Alginate+Hydrocolloid dressings.- Povidone iodine +Hydrogen peroxide dressings.- Normal Saline soaked gauze dressings.Materials and methods Randomised Prospective study.3 group of patients- Group (A)- Alginate+hydrocolloid dressings.- Group (B)- Povidone iodine+hydrogen peroxide dressing- Group (C)- Normal saline soaked gauze dressings.For classification of wounds, S(AD)SAD classification system was used.Study period - September 2011 to November 2013.Criteria INCLUSION CRITERIA-(A). Type 1 or Type 2 diabetic patients with foot ulcers.(B). Age 18 years or above.(C). Able and willing to give informed consent.EXCLUSION CRITERIA-(A). Patients with peripheral vascular disease.(B). Patients with known allergy to iodine.(C). Patients on immunosuppressive/corticosteroid therapy

S(AD) SAD ClassificationGrade Area DeepSepsisArteriopathyDenervation 0Skin intactSkin intactIntact 1Lesion 3cm2Lesion in bones & jointsOsteomyelitisGangrene Charcot joint

All patients were followed up personally after 1 week, 15 days, 1 month and 3 months.Size of the ulcer was measured on a transparent sheet using a marker pen at first visit and on subsequent follow up visits.Follow Up CriteriaUlcer Size on transparency:Floor:Discharge:Surrounding Area:Signs of inflammation:GRBS :

Follow UpAll patients seen personally.Total 46 patients.Lost to follow up / excluded 13 patients. Final Analysis 33Group A 10 patientsGroup B 13 patientsGroup C 10 patientsFollow upGroup A 10 patients.

Group B 13 patients.

Group C 10 patients.

Results DescriptivesAge NMeanStd. DeviationStd. Error95% Confidence Interval for MeanMinimumMaximumLower BoundUpper Bound11062.808.8792.80856.4569.15447221355.4612.1773.37748.1062.82297431061.707.7752.45956.1467.264571Total3359.5810.3111.79555.9263.232974ANOVA F=1.826, P=0.179

Results Factors Group AGroup BGroup CComorbidities Hypertension 5Hypertension 5IHD 3Hypertension 6Duration of Diabetes5 years5 years5 yearsPatient Insulin / OHAOHA 6Insulin 4OHA 6Insulin 7OHA 7Insulin 4History of Foot related complications321Smoking 342Total Leucocyte Count10,00010,00011,000GRBS at first visit230228221X ray footNo osteomyelitisOsteomyelitis 1Osteomyelitis 1Arterial DopplerNot done2 normal2 normalFirst VisitGroup AGroup BGroup CUlcer Size10x15 3x3 cm12x10 3x3 cm10x8 3x4 cmPlantar Location687Floor Slough 6Slough 7Slough - 6Vascularity (ABI)Good Good Good Signs of Inflammation (+)676Debridement done535SAD Score3-73-83-7Follow upFollow UpGroup AGroup BGroup CReduction in Size on TransparencyMax 100%Min 20%Max- 100%Min 10%Max 100%Min 25%Complete Healing of Wound464FloorHealthyHealthyHealthyDischarge234Surrounding AreaNormal NormalNormalInflammation No No NoDiabetic status>200 4>200 5>200 - 5Group AComplete Healing within 3 months 450 % Size Reduction -3< 50% Size reduction - 3

1 patient developed wound infection after 2 months follow up, but was managed with debridement.Group BComplete healing within 3 months -6Size reduction 50 % - 4Size reduction 10-30 % 3Group CComplete healing within 3 months - 4Size reduction 50 % -4Size reduction 25 % -2SAD score & wound healing Odds ratio =0.769( 95% CI (0.301, 1.968) , P=0.584With every 1 unit increase in SAD score, healing of ulcers decreased upto 25 %.

Variables in the EquationDressingBS.E.WalddfP valueOdds ratio95% C.I.for EXP(B)LowerUpperAHStep 1aSADScore-.262.479.2991.584.769.3011.968Constant.8392.343.1281.7202.314BHStep 1aSADScore-1.168.7262.5901.108.311.0751.290Constant5.7423.7122.3931.122311.702NSStep 1aSADScore-.128.401.1021.750.880.4011.932Constant.3192.353.0181.8921.376a. Variable(s) entered on step 1: SADScore.Review of LiteratureComparison with LiteratureFoam dressings were associated with higher odds of ulcer healing compared with basic wound contact dressings. Estimate was considered to be of low quality. In general, estimates had large uncertainty due to low sample sizes.No significant difference between foam dressings v/s basic contact dressings.Dumville JC, Soares MO, OMeara S, Cullum N (2012) Systematic review and mixed treatment comparison: dressings to heal diabetic foot ulcers. Diabetologia 55 : 19021910Review of LiteratureFoot ulcers occur in 12-25% patients with diabetes.Precedes 84% of all non-traumatic amputations.Amputations are 15 times more common in patients with Diabetes.Standard care heals 24% of ulcers in 24 weeks.- Removal of mechanical stress.- Debridement.- Moist wound environment.Brem H., Sheehan P., Rosenberg H.J., Schneider J S., Boulton A J. et al (2006) Evidence-Based Protocol for Diabetic Foot Ulcers. Plastic and Reconstructive Surgery. 117; 193-209Alginate + Hydrocolloid DressingsAlginates are highly absorbent, gel-forming materials with haemostatic properties.Calcium alginate dressings inhibits growth of Staphylococcus aureus in vitro, with no increase in growth of Pseudomonas, Streptococcus pyogenes, or Bacteroides fragilis.Safe to use on infected foot ulcers, provided there are regular and thorough dressing changes.Hydrocolloids provide moist environment.Hilton J.R., Williams D.T., Beuker B., Miller D.R., Harding K.G (2004) Wound Dressings in Diabetic Foot Disease. Clinical Infectious Diseases 39; 100-103Povidone-iodine + Hydrogen Peroxide DressingsPovidone iodine - decreases bacterial count of ulcers,- promote revascularization,- do not cause the emergence of drug-resistance- have broader antimicrobial spectrum.Hydrogen peroxide - wound antiseptic.- greatest activity is towards Gram-positive bacteria.- loosens debris and necrotic tissue of wound.In-vitro studies Povidone iodine shown to be cytotoxic to cells essential to the wound healing process, such as fibroblasts, keratinocytes, leukocytes.Brem H., Sheehan P., Rosenberg H.J., Schneider J S., Boulton A J. et al (2006) Evidence-Based Protocol for Diabetic Foot Ulcers. Plastic and Reconstructive Surgery. 117; 193-209Normal Saline DressingsPhysiologically normalIsotonic with plasmaProvide moist environment for healing of wounds.As the water in gauze evaporates, dressing becomes hypertonic, draws fluid from wound by osmosis.Wound fluid then dilutes - to reach dynamic equilibrium.Movement of wound fluid into sponge contribute to its effectiveness as a dressing.Lim J.K., Saliba L, Smith M.J., McTavish J., Raine C. et al. Normal saline wound dressing is it really normal?: British Journal of Plastic Surgery: 2000; 53; 4245.

Limitations Small sample size.Conclusion No significant difference between clinical outcome of 3 types dressings in diabetic foot ulcers.

SAD score helps in predicting healing of ulcers.Thank You34