{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T06:16:12Z","timestamp":1794550572081,"version":"4.9.1"},"reference-count":42,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T00:00:00Z","timestamp":1719014400000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"AVS Research Fund of The Ministry of Fisheries in Iceland","award":["R 18 044-18 for the research project \u201cChitoCare"],"award-info":[{"award-number":["R 18 044-18 for the research project \u201cChitoCare"]}]},{"name":"AVS Research Fund of The Ministry of Fisheries in Iceland","award":["R 19 044-18 for the research project \u201cChitoCare"],"award-info":[{"award-number":["R 19 044-18 for the research project \u201cChitoCare"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Diab Res Care"],"accepted":{"date-parts":[[2024,6,7]]},"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>To assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Research design and methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>ChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04178525\">NCT04178525<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjdrc-2024-004195","type":"journal-article","created":{"date-parts":[[2024,6,23]],"date-time":"2024-06-23T10:35:10Z","timestamp":1719138910000},"page":"e004195","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study)"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04178525","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04178525","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6339-6060","authenticated-orcid":false,"given":"Matev\u017e","family":"Slivnik","sequence":"first","affiliation":[{"name":"Vizera d.o.o, Ljubljana, Slovenia"},{"name":"University of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Navodnik Prelo\u017enik","sequence":"additional","affiliation":[{"name":"General Hospital Celje, Celje, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mojca","family":"Fir","sequence":"additional","affiliation":[{"name":"Vizera d.o.o, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janja","family":"Jazbar","sequence":"additional","affiliation":[{"name":"University of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan\u010da","family":"\u010cebron Lipovec","sequence":"additional","affiliation":[{"name":"University of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0052-8986","authenticated-orcid":false,"given":"Igor","family":"Locatelli","sequence":"additional","affiliation":[{"name":"University of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Liette Lauzon","sequence":"additional","affiliation":[{"name":"Primex ehf, Siglufj\u00f6r\u00f0ur, Iceland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vilma","family":"Urban\u010di\u010d Rovan","sequence":"additional","affiliation":[{"name":"University Medical Centre Ljubljana, Ljubljana, Slovenia"},{"name":"University of Ljubljana Faculty of Medicine, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,6,23]]},"reference":[{"key":"2025073112252906000_12.3.e004195.1","unstructured":"International Diabetes Federation . 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