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This protocol outlines a pilot trial and qualitative study investigating ESWT in DFU healing. A pilot three arm placebo controlled double\u2010blinded randomised controlled trial. Participants with a DFU will be randomised to high dose (500 shocks\/cm<jats:sup>2<\/jats:sup>), low dose (100 shocks\/cm<jats:sup>2<\/jats:sup>) or sham ESWT, in addition to standard care. The primary outcome will be deliverability of a definitive trial. Secondary outcomes are ulcer healing, quality\u2010of\u2010life and healthcare resource use at 6\u2009months. The target sample size is 90 participants. The study is registered on <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link>, reference: NCT05380544 and has ethical approval (REC reference: 22\/WA\/0089). The qualitative interview study will recruit participants who complete, drop\u2010out and decline to participate in the pilot trial, and healthcare professionals who deliver DFU care. Maximum variable sampling will be used to recruit participants. Data will be analysed with an inductive exploratory approach using reflexive thematic analysis. The pilot trial will ensure methods used will address the research question in the definitive trial. The qualitative study will explore how patients and clinicians interact with the trial to understand the pilot trial findings.<\/jats:p>","DOI":"10.1111\/iwj.70176","type":"journal-article","created":{"date-parts":[[2025,3,31]],"date-time":"2025-03-31T23:26:25Z","timestamp":1743463585000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (<scp>SOLEFUL<\/scp>): A Study Protocol"],"prefix":"10.1111","volume":"22","author":[{"given":"L.","family":"Hitchman","sequence":"first","affiliation":[{"name":"Faculty of Clinical Sciences Hull York Medical School  Hull UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Iglesias","sequence":"additional","affiliation":[{"name":"Department of Health Sciences University of York  York England"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Russell","sequence":"additional","affiliation":[{"name":"Leeds Vascular Institute, Teaching Hospitals NHS Trust  Leeds UK"},{"name":"Leeds Institute of Clinical Trials Research, University of Leeds  Leeds UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Smith","sequence":"additional","affiliation":[{"name":"Faculty of Clinical Sciences Hull York Medical School  Hull UK"},{"name":"Hull University Teaching Hospitals NHS Trust  Hull UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Twiddy","sequence":"additional","affiliation":[{"name":"Institute of Clinical and Applied Sciences, Hull York Medical School  Hull UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I. 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