{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T18:27:33Z","timestamp":1788805653990,"version":"build-2803163510"},"reference-count":22,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T00:00:00Z","timestamp":1684713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Department of Clinical Medicine and Surgery of the Federico II University Hospital"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: The use of dressings is an essential component of the standard of care for diabetic foot ulcers (DFUs); however, despite the wide variety of dressings available, there is a lack of evidence from head-to-head randomized controlled trials. We evaluated the efficacy and safety of Triticum vulgare extract and polyhexanide (Fitostimoline\u00ae hydrogel\/Fitostimoline\u00ae Plus gauze) versus saline gauze dressings in patients with DFUs. Methods: This study involved a monocentric, two-arm, open-label, controlled trial in patients with DFUs (Grades I or II, Stage A or C, based on the Texas classification) randomized to 12 weeks of dressing with Fitostimoline\u00ae hydrogel\/Fitostimoline\u00ae Plus gauze or saline gauze. The number of patients with complete healing, the reduction in DFU size, and the presence of local signs and symptoms of the wound and perilesional skin were evaluated every two weeks and at the end of treatment. Results: A total of 40 adult patients were recruited (20 patients in each treatment group). The proportion of patients with complete healing was similar between the two groups (61% vs. 74%, p = 0.495, Fitostimoline\u00ae hydrogel\/Fitostimoline\u00ae Plus gauze vs. saline gauze, respectively), without significant differences, as well as the reduction in DFU size. A significant improvement in local signs and symptoms of the wound and signs of perilesional skin in the Fitostimoline\u00ae hydrogel\/Fitostimoline\u00ae Plus gauze compared with the saline gauze group was observed. Conclusions: In a clinical setting, the use of Fitostimoline\u00ae hydrogel\/Fitostimoline\u00ae Plus gauze dressing in patients with DFUs significantly improves signs and symptoms of the wound and signs of perilesional skin compared with saline gauze dressing with a similar efficacy in terms of wound healing.<\/jats:p>","DOI":"10.3390\/jcm12103596","type":"journal-article","created":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T05:49:32Z","timestamp":1684734572000},"page":"3596","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Triticum vulgare Extract and Polyhexanide (Fitostimoline\u00ae Hydrogel\/Fitostimoline\u00ae Plus Gauze) versus Saline Gauze Dressing in Patients with Diabetic Foot Ulcers: Results of a Randomized Controlled Trial"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5862-3794","authenticated-orcid":false,"given":"Giuseppe","family":"Della Pepa","sequence":"first","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"},{"name":"Cardiometabolic Risk Unit, Institute of Clinical Physiology, National Research Council\u2014CNR, 56100 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluca","family":"Lombardi","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Gianfrancesco","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6981-3814","authenticated-orcid":false,"given":"Roberto","family":"Piccolo","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2466-1332","authenticated-orcid":false,"given":"Giovanni","family":"Chirico","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micaela","family":"Pellegrino","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Santella","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0509-3886","authenticated-orcid":false,"given":"Nicola","family":"Tecce","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anastasia","family":"Volpicelli","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Sollo","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6549-4476","authenticated-orcid":false,"given":"Lutgarda","family":"Bozzetto","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Masulli","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Riccardi","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela Albarosa","family":"Rivellese","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gennaro","family":"Saldalamacchia","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine and Surgery, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,5,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"107843","DOI":"10.1016\/j.diabres.2019.107843","article-title":"Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition","volume":"157","author":"Saeedi","year":"2019","journal-title":"Diabetes Res. 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