The efficacy of topical phenytoin in the healing of diabetic foot ulcers: a randomized double-blinded trial

A randomized, double-blinded, controlled clinical trial was conducted to assess the efficacy of topical phenytoin compared to conventional wound care in improving the healing process and to prove it as a relatively low-cost and easy-to-use option in the management of diabetic ulcers. Patients over 18 years of age with type 2 diabetes and foot ulcers over 1 month duration were randomized to receive daily dressings containing either powder A (test powder containing topical phenytoin and metronidazole) or powder B (control powder containing topical metronidazole) for 14 days, following which, they underwent split-skin grafting. The percentage of decrease in the ulcer surface area, rate of granulation tissue formation, graft uptake, and percentage of negative culture sensitivity were compared between the two groups using the unpaired Student’s t test. A p value <0.05 was considered significant. Patient demographic and socioeconomic characteristics of the two groups were well matched. The primary outcome measured as the mean rate of decrease of size of the ulcer in patients of group A was 30.69 (±5.50 SD) and in group B was 24.43 (±5.96 SD) percent of total ulcer area (p < 0.0001). The mean rate of increase of granulation tissue in group A was 69 (±10.16 SD) percent of total ulcer area and in group B was 51.51 (±10.54 SD) percent of total ulcer area (p < 0.0001). Out of the 97 patients, 75 underwent grafting. The mean graft take up in group A was 76.57 % (±19.06 SD) and in group B was 66.48 % (±17.67 SD) (p = 0.0082). Forty-three percent of the study group was culture negative at day 14, of which 54.2 % belonged to group A as compared to 45.8 % in group B. Topical phenytoin is an effective, inexpensive, and easily available agent in the promotion of healing of diabetic foot ulcers.