The Effect of Topical Cow's Milk on the Healing of Diabetic Foot Ulcers: A Randomized Controlled Pilot Clinical Trial.

Abstract

Diabetic foot ulcer (DFU) is a very serious side effect among the diabetic patients with substantial clinical and economic consequences. The aim of this study was to investigate the efficacy of cows' milk topical ointment, as an available and cost-effective natural product, on accelerating the healing of DFU. In this randomized controlled clinical trial, patients with grade 1 or 2 DFU were randomly divided into two groups of intervention (n = 50) and control (n = 49). For patients of intervention group, cows' milk 20% topical ointment was applied on the ulcer once daily for two weeks, while a type of novel dressing was used for control group with the same frequency and duration. Both groups received usual standard wound care measures. The percentage of change in the ulcer size and the number of cases with complete wound healing (>90% reduction in the ulcer size) were recorded in the both groups. The ulcer size significantly reduced in both groups on the seventh and 14^th days of intervention; however, the percentage of reduction was significantly higher in the intervention (milk) group compared to control at both time points (44.64 ± 15.98 vs. 24.95 ± 12.78, P < .001; 67.67 ± 22.15 vs. 42.87 ± 19.74, P < .001). Furthermore, although more patients in the intervention group (n = 4, 8%) showed complete healing of the ulcer compared to control (n = 0), the difference was not statistically significant (P = .117). Cow's milk 20% topical ointment improves and accelerates the healing of diabetic foot ulcers. However, more clinical studies are required to confirm these effects.