A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND studySlivnik, Matevž (Avtor) Navodnik-Preložnik, Maja (Avtor) Japelj Fir, Mojca (Avtor) Jazbar, Janja (Avtor) Čebron Lipovec, Nanča (Avtor) Locatelli, Igor (Avtor) Lauzon, Hélène Liette (Avtor) Urbančič-Rovan, Vilma (Avtor) clinical studydiabetes complicationsdiabetic footwound healingIntroduction: 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.20242026-06-04 12:56:10Neznano29749UDK: 616.379-008.64-06:616.7+616-003.93ISSN pri članku: 2052-4897DOI: 10.1136/bmjdrc-2024-004195COBISS_ID: 199834883sl