Efficacy and safety of chitosan-based bio-compatible dressing versus nanosilver (ActicoatTM ) dressing in treatment of recalcitrant diabetic wounds: A randomized clinical trial.

Abstract

Chitosan has a biocompatible, biodegradable, and nontoxic nature. The effectiveness of Nano-chitosan films in the field of wound healing has been confirmed previously.The aim of this study was to compare the clinical efficacy and safety of two dressings (chitosan and nanosilver dressings) in the treatment of refractory diabetic wounds. A total of 25 eligible patients with chronic diabetic wound were included and randomly assigned to receive chitosan (13 patients) or nanosilver (12 cases) dressing. The dressings were applied on the wounds based on their protocols and patients were visited and examined by an experienced dermatologist every week. The clinical assessments and healing rates were recorded using diabetic-foot-infection (DFI) score at the 2nd, 4th, and 6th weeks during treatment. The study endpoint, safety and tolerability profile were also documented. The patterns of change in total 10-item-DFI wound scores did not differ significantly over time between the two groups. In both groups, the total 10-item-DFI wound score reduced continuously through the course of study. The mean percentage reduction of this score from baseline was 78.1% and 74.1% in the chitosan and nanosilver dressing groups, respectively. Both dressings were well tolerated and there were no adverse events. The relatively small sample size in both groups was the main limitation of the study. Our findings confirmed that chitosan may be safely and effectively used for the treatment of diabetic wounds just like the nanosilver (ActicoatTM ) dressing. Further studies are recommended with more volunteers and a longer follow-up period.