{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:01:35Z","timestamp":1787162495884,"version":"build-2736575974"},"reference-count":26,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T00:00:00Z","timestamp":1744588800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["NIHR155477"],"award-info":[{"award-number":["NIHR155477"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>Background Venous leg ulceration (VLU) is the most severe form of venous disease and an important burden to patients and society. Many treatments for VLU exist, including wound therapies, medications, and surgical interventions. However, high-level randomized trial data supporting leg ulcer treatments are lacking, limiting their adoption in clinical practice. We developed a platform trial assessing multiple interventions for VLU comprising multiple multi-arm multi-stage trials. Methods Scoping reviews, surveys, meetings, and focus groups were conducted over five work streams to inform the development of the proposed platform trial. We involved international experts in venous disease, patients with a lived experience of VLU, healthcare professionals with an interest in VLU care, methodologists, industry partners, and other key stakeholders to help inform priority research areas and methodology, and finalize the proposed trial design. Results Based on this feedback, the proposed multi-arm multi-stage (MAMS) platform trial will be delivered across three patient domains: patients with active ulceration present for less than six months (Domain 1), patients with active ulceration present for more than six months (Domain 2), and patients with healed ulceration (Domain 3). Interventions included wound care, medication, intervention for superficial venous reflux, and surveillance strategies delivered across community, primary, and secondary care. Conclusions Our MAMS platform trial development highlighted many challenges and opportunities in methodology development and the potential delivery of such a study. The work performed in our work streams will help inform future research in this field.<\/ns3:p>","DOI":"10.3310\/nihropenres.13847.1","type":"journal-article","created":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T07:20:05Z","timestamp":1744615205000},"page":"32","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Designing a multi-arm, multi-stage platform trial for venous leg ulceration \u2013 Venous leg ulcers: management and eradication, the VEIN platform study."],"prefix":"10.3310","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5926-4578","authenticated-orcid":false,"given":"Sarah","family":"Onida","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alun Huw","family":"Davies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"VEIN Platform 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The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":2,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}