| Title: | A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study |
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| Authors: | ID Slivnik, Matevž (Author)
ID Navodnik-Preložnik, Maja (Author)
ID Japelj Fir, Mojca (Author)
ID Jazbar, Janja (Author)
ID Čebron Lipovec, Nanča (Author)
ID Locatelli, Igor (Author)
ID Lauzon, Hélène Liette (Author)
ID Urbančič-Rovan, Vilma (Author) |
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| Files: |  PDF - Presentation file, download (898,48 KB)
MD5: 1762876DB02A702ACEE591F5B1CE7900
 URL - Source URL, visit https://drc.bmj.com/content/12/3/e004195.full
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| 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. |
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| Keywords: | clinical study, diabetes complications, diabetic foot, wound healing |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2024 |
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| Number of pages: | 10 str. |
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| Numbering: | Vol. 12, no. 3, [article no.] e004195 |
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| PID: | 20.500.12556/DiRROS-29749  |
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| UDC: | 616.379-008.64-06:616.7+616-003.93 |
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| ISSN on article: | 2052-4897 |
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| DOI: | 10.1136/bmjdrc-2024-004195 |
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| COBISS.SI-ID: | 199834883 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 26. 6. 2024;
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| Publication date in DiRROS: | 04.06.2026 |
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| Views: | 101 |
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| Downloads: | 79 |
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