{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T16:43:32Z","timestamp":1765471412780,"version":"3.48.0"},"reference-count":30,"publisher":"Mark Allen Group","issue":"S11a","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Wound Care"],"published-print":{"date-parts":[[2025,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To describe real-world outcomes and safety associated with Relese (StimLabs, US), a fenestrated dehydrated complete human placental membrane (dCHPM), as an adjunct to standard of care (SoC) for hard-to-heal (chronic) ulcers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method:<\/jats:title>\n                    <jats:p>A retrospective observational audit of adults with ulcers of \u22654 weeks' duration, despite SoC, treated with the dCHPM at three US centres from May 2023 to April 2025. Outcomes were summarised descriptively and included: complete closure rate; time to closure; closure category; percentage area reduction (PAR); and number of applications to closure. Safety outcomes included wound-related adverse events (AEs), amputation and mortality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 23 patients with 26 ulcers (42% diabetic foot ulcers; 46% neuropathic; 12% other) were included. In the intent-to-treat (ITT) population, 54% of ulcers achieved complete closure; in the per-protocol (PP) population, 78% closed. Median time to closure was 49 days, with a median of 5.5 applications. At week 12, mean PAR was 56% in the ITT population (77% \u226550% PAR) and 86% in the PP population (100% \u226550% PAR). AEs occurred in 30% of patients, most commonly, local infection (26%) and inflammation (13%). In addition, one amputation and two hospitalisations occurred, none of which were considered related to use of the dCHPM. No serious AEs related to the dCHPM were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this audit, the dCHPM was associated with timely closure and favourable safety outcomes in real-world practice. These descriptive findings may contribute to the growing body of real-world evidence supporting full-thickness placental membranes as adjuncts to SoC in the treatment of hard-to-heal ulcers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.12968\/jowc.2025.0499","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T17:33:00Z","timestamp":1761586380000},"page":"S32-S40","source":"Crossref","is-referenced-by-count":0,"title":["Use of Relese in the treatment of hard-to-heal ulcers: a retrospective, multicentre real-world study"],"prefix":"10.12968","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-1169-5768","authenticated-orcid":false,"given":"Katherine W","family":"Freeland","sequence":"first","affiliation":[{"name":"Premier Foot & Ankle, Frisco, TX, US"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matt D","family":"Ramirez","sequence":"additional","affiliation":[{"name":"Premier Foot & Ankle Sherman, Denison, TX, US"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley M","family":"Wakelee","sequence":"additional","affiliation":[{"name":"Cypress Wound Care, Oklahoma City, OK, US"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"5130","reference":[{"doi-asserted-by":"publisher","key":"B1","DOI":"10.12968\/jowc.2023.32.Sup4b.S1"},{"doi-asserted-by":"publisher","key":"B2","DOI":"10.3390\/bioengineering10070829"},{"doi-asserted-by":"publisher","key":"B3","DOI":"10.1155\/2022\/6751456"},{"issue":"1","key":"B4","first-page":"20","volume":"33","author":"Koullias GJ","year":"2021","journal-title":"Wounds"},{"doi-asserted-by":"publisher","key":"B5","DOI":"10.1002\/term.3086"},{"unstructured":"StimLabs LLC. Relese: a selective barrier designed to provide protection for acute and chronic wounds. 2025. https:\/\/stimlabs.com\/relese\/ (accessed 16 October 2025)","key":"B6"},{"issue":"12","key":"B7","first-page":"38","volume":"59","author":"Regulski M","year":"2013","journal-title":"Ostomy Wound Manage"},{"doi-asserted-by":"publisher","key":"B8","DOI":"10.1111\/iwj.12649"},{"doi-asserted-by":"publisher","key":"B9","DOI":"10.1111\/wrr.12503"},{"doi-asserted-by":"publisher","key":"B10","DOI":"10.1111\/iwj.12329"},{"doi-asserted-by":"publisher","key":"B11","DOI":"10.1089\/wound.2017.0743"},{"unstructured":"Centers for Medicare & Medicaid Services. Billing and coding: skin substitute grafts\/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers (A57680). https:\/\/tinyurl.com\/29dkueuu (accessed 22 October 2025)","key":"B12"},{"unstructured":"Code of Federal Regulations. Food and Drug Administration, Department of Health and Human Services. Subchapter L. Part 1271. https:\/\/tinyurl.com\/2r68frhm (accessed 22 October 2025)","key":"B13"},{"doi-asserted-by":"publisher","key":"B14","DOI":"10.1089\/wound.2015.0635"},{"doi-asserted-by":"publisher","key":"B15","DOI":"10.1016\/j.jvs.2015.10.003"},{"doi-asserted-by":"publisher","key":"B16","DOI":"10.1111\/wrr.12391"},{"doi-asserted-by":"publisher","key":"B17","DOI":"10.1002\/dmrr.3266"},{"doi-asserted-by":"publisher","key":"B18","DOI":"10.12968\/jowc.2022.31.Sup9.S16"},{"doi-asserted-by":"publisher","key":"B19","DOI":"10.1097\/01.ASW.0000305486.06358.e0"},{"doi-asserted-by":"publisher","key":"B20","DOI":"10.1111\/wrr.12538"},{"doi-asserted-by":"publisher","key":"B21","DOI":"10.25270\/wnds\/2021.329333"},{"issue":"12","key":"B22","first-page":"e76262","volume":"16","author":"Fife C","year":"2024","journal-title":"Cureus"},{"doi-asserted-by":"publisher","key":"B23","DOI":"10.1089\/wound.2024.0141"},{"unstructured":"Centers for Medicare & Medicaid Services. Local coverage determination (LCD): skin substitute grafts\/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers (L39806). 2025. https:\/\/tinyurl.com\/kbrwt57a (accessed 16 October 2025)","key":"B24"},{"unstructured":"Centers for Medicare & Medicaid Services. Proposed guidance document: study protocols that use real-world data. 2025. https:\/\/tinyurl.com\/3w5b3e6c (accessed 16 October 2025)","key":"B25"},{"doi-asserted-by":"publisher","key":"B26","DOI":"10.12968\/jowc.2024.0139"},{"doi-asserted-by":"publisher","key":"B27","DOI":"10.1111\/wrr.12635"},{"doi-asserted-by":"publisher","key":"B28","DOI":"10.57264\/cer-2025-0092"},{"doi-asserted-by":"publisher","key":"B29","DOI":"10.1101\/cshperspect.a041243"},{"doi-asserted-by":"publisher","key":"B30","DOI":"10.2337\/diacare.26.6.1879"}],"container-title":["Journal of Wound Care"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.magonlinelibrary.com\/doi\/pdf\/10.12968\/jowc.2025.0499","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T16:40:07Z","timestamp":1765471207000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.magonlinelibrary.com\/doi\/10.12968\/jowc.2025.0499"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,1]]},"references-count":30,"journal-issue":{"issue":"S11a","published-print":{"date-parts":[[2025,11,1]]}},"alternative-id":["10.12968\/jowc.2025.0499"],"URL":"https:\/\/doi.org\/10.12968\/jowc.2025.0499","relation":{},"ISSN":["0969-0700","2052-2916"],"issn-type":[{"type":"print","value":"0969-0700"},{"type":"electronic","value":"2052-2916"}],"subject":[],"published":{"date-parts":[[2025,11,1]]}}}