A Randomized, Placebo-controlled Study of Chitosan Gel for the Treatment of Chronic Diabetic Foot Ulcers (the CHITOWOUND Study)

Overview

Journal BMJ Open Diabetes Res Care

Specialty Endocrinology

Date 2024 Jun 23

PMID 38909998

Authors

Matevz Slivnik

Maja Navodnik Preloznik

Mojca Fir

Janja Jazbar

Nanca cebron Lipovec

Igor Locatelli

Helene Liette Lauzon

Vilma Urbancic Rovan

Affiliations

Soon will be listed here.

Abstract

Introduction: To assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs).

Research Design And Methods: Forty-two patients with chronic DFUs were randomized to the ChitoCare or placebo gel for a 10-week treatment period and 4-week follow-up. The primary study end point was the rate of complete wound closure at week 10, presented as relative rate.

Results: Thirty patients completed the 10-week treatment and 28 completed the 4-week follow-up. The ChitoCare arm achieved 16.7% complete wound closure at week 10 vs 4.2% in the placebo arm (p=0.297), 92.0% vs 37.0% median relative reduction in wound surface area from baseline at week 10 (p=0.008), and 4.62-fold higher likelihood of achieving 75% wound closure at week 10 (p=0.012). Based on the results of the Bates-Jensen Wound Assessment Tool, the wound state at week 10 and the relative improvement from the baseline were significantly better (median 20 vs 24 points, p=0.018, and median 29.8% vs 3.6%, p=0.010, respectively).

Conclusions: ChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel.

Trial Registration Number: NCT04178525.

Citing Articles

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