15th World Congress Clinical Nutrition

19th – 22nd September 2010  El Sokhna Resort -  Egypt

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Evaluation of herbal formulation as an effective wound healing agent in Diabetic foot ulcers

K Reddy, I Nagaraju, Dattatreya Rao ,C Reddy Depart Anthropology, S.V. University, Tirupati- India

Objective: Diabetic foot ulcers (DFUs), a leading cause of amputations, affect 15% of people with diabetes. The main objective of the study was to evaluate the safety and healing rates of a herbal formulation in the treatment of chronic foot ulcers in diabetic patients.

Design and Setting: Open label prospective clinical trial at S.V. Ayurvedic hospital in Tirupati.

Interventions: The study duration is 45 days. Eight patients (7 males + one female) were recruited with secondary failure to standard medication. Clinical measures included standard ayurvedic antidiabetic treatment, daily wound care including antiseptic bath. The primary outcome measures were: wound closure. At the same time, the rate of ulcer healing, erythema, edema, scabbing and reepithelialization were taken as supportive outcome measures. The target wound's greatest length and width was measured at baseline and then every two weeks till the study duration. The target wound was also photographed at baseline and then every two weeks. Wagner’s grading of foot lesions was followed to classify the ulcers. Treatment consists of an herbal formulation (oil based) with water soluble extracts of Azadiracta indica bark, Glycyrhiza glabra root, Curcuma longa rhizome further extracted into Sesamum indicum seed oil (patent pending), given as topical application daily once. Treatment continued after the study duration till the wound healing upon patient request.

Results: The mean age of the patients was 55.37±13.81. The mean duration of diabetes among the subjects was 7.25±2.55 years and the mean ulcer duration was 5.38±2.20 years. Mean ulcer size at baseline was 83.06±119.33 cm and on 45th day the size was 26.50±39.72; p<0.196). Overall there was 68 percent reduction in ulcer size over a period of 45 days. The mean scores on irritation markers like erythema (09.42±0.66 vs. 05.08±1.02; p<0.05), edema (08.92±1.11 vs. 0.67±0.61;p<0.05) significantly reduced and re-epithelialization (0.83±0.75 vs. 3.00±0.71; p<0.05) significantly increased between day zero and day 45. No serious adverse events were observed.

Conclusion: The herbal adjuvant therapy was effective in helping the healing of chronic diabetic ulcers.




   
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