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The primary outcomes were the percentage of ulcers healed 6\u2009weeks after treatment commenced. The secondary outcomes were the average healing time, the time course of the healing process, the local tolerance, and the acceptability of the treatment by the patient compared to the standard treatment. At the 6\u2009weeks end\u2010of\u2010treatment visit (ETV), 56.5% of the patients in the RegenWound gel group and 20.0% of the patients in the control group had completely healed. Healing continued to evolve after the ETV and reached 77.3% at end\u2010of\u2010study visit 2 (12\u2009weeks) in the RegenWound gel group, compared to 35.1% for the control group. The treatment was well tolerated and safe. RegenWound gel could be an effective treatment for diabetic foot ulcers, with most patients being healed within 6\u2009weeks of treatment, and on average 1 to 2 treatments being needed.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> ISRCTN10032417<\/jats:p>","DOI":"10.1111\/iwj.70495","type":"journal-article","created":{"date-parts":[[2025,4,17]],"date-time":"2025-04-17T02:17:11Z","timestamp":1744856231000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A Randomised Controlled Clinical Study Comparing the Efficacy and Safety of an Autologous Standardised Leukocyte\u2010Poor Platelet Gel With Standard Care for the Treatment of Chronic Neuropathic Diabetic Foot Ulcers"],"prefix":"10.1111","volume":"22","author":[{"given":"Sylvaine","family":"Clavel","sequence":"first","affiliation":[{"name":"Department of Endocrinology SOS Group\u2013Hotel Dieu  Le Creusot France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"Denizot","sequence":"additional","affiliation":[{"name":"Pre\u2010Re\u2010Diab Network  Le Creusot France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Bo\u00ebzennec","sequence":"additional","affiliation":[{"name":"RegenLab SA  Le Mont\u2010sur\u2010Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Turzi","sequence":"additional","affiliation":[{"name":"RegenLab SA  Le Mont\u2010sur\u2010Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nizar","family":"Albache","sequence":"additional","affiliation":[{"name":"Department of Endocrinology SOS Group\u2013Hotel Dieu  Le Creusot France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.8.1354"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67699-4"},{"issue":"10","key":"e_1_2_11_4_1","first-page":"69","article-title":"Impacts du Vieillissement de la Population et de L'ob\u00e9sit\u00e9 sur l\u2019\u00e9volution de la Pr\u00e9valence du Diab\u00e8te Trait\u00e9: Situation en France M\u00e9tropolitaine \u00e0 l'horizon 2016","author":"Bonaldi C.","year":"2006","journal-title":"Bulletin Epidemiologique Hebdomadaire"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.27.9.2129"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1067-1927.2005.130303.x"},{"issue":"34","key":"e_1_2_11_7_1","first-page":"619","article-title":"Le poids des complications li\u00e9es au diab\u00e8te en France en 2013. 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