Evaluation of the effect of Cow milk topical ointment on diabetic foot ulcer and bedsore healing

Determining the effectiveness of topical milk ointment in the healing of diabetic foot ulcer and bedsore

Two arm parallel group randomised trial with control group

The study will be performed in Al-Zahra hospital of Isfahan. Patients with the inclusion criteria will be randomly assigned to drug or control groups. The sample size is 60 patients.For patients in drug group, milk 20% topical ointment will be applied for two weeks, while for patients of control group, specific dressing (Aquacel-Ag) will be used for two weeks. At the end of 7th and 14th day of intervention, the percent of wound size reduction and the erythema status will be recorded. Furthermore, the number of cases with complete wound healing during the study will be recorded for both groups. Finally, the mentioned variables will be compared between the groups.

Inclusion criteria: 1. Age of 18 years-old or more 2. Diabetic foot ulcer grade 1 or 2 or bedsore stage 2 or 3 Exclusion criteria: 1. Smoking 2. Coagulopathy

Drug Group: Topical ointment 20% cow's milk (made by faculty of pharmacy of Isfahan university of medical sciences), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks Control Group: Specific dressing (Aquacel-Ag, made by Convatec company, USA), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks

1. The percent of decrease in the wound size 2. The number of cases of complete wound healing

Simple randomization method will be used. For this, patients with even and odd medical profile numbers, respectively, will be assigned to drug and control groups.

There is no necessity.