Comparing Hypochlorous Acid and Polyhexamethylene Biguanide for Treating Diabetic Foot Ulcers A Double-Blind Randomized Clinical Trial

What this Trial Is About

Researchers are studying diabetic foot ulcers DFU in people with diabetes to compare the effectiveness of two topical antimicrobial agents in helping ulcers heal. The goal is to find out if cleaning DFU with Hypochlorous Acid HClO leads to faster complete healing than cleaning with Polyhexamethylene biguanide PHMB. This randomized, double-blind, controlled trial involves 202 participants and aims to measure time to healing as the primary outcome over 24 weeks. Participants will be randomly assigned to have their diabetic foot ulcers cleaned twice a week with either Dakins Solution containing Hypochlorous Acid or Prontosan containing PHMB. Both treatments will be applied following specific instructions until the ulcer is fully healed or for up to 24 weeks. The study also explores differences in healing patterns, ulcer size, depth, antibiotic use, quality of life, and cost effectiveness between the two treatments. During the study, participants will undergo regular wound cleaning sessions twice weekly with either HClO or PHMB. Researchers will assess healing progress by measuring the time until the ulcer is completely covered with intact skin. Additional evaluations include changes in ulcer size and depth, antibiotic use, and quality of life questionnaires EQ-5D and SF-12. Safety and treatment effects will be monitored throughout the 24-week treatment period.

Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan