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This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty\u2010three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12\u2009weeks. There were significantly more wounds closed in the treatment group (18\/25; 72%) vs controls (8\/25; 32%) at 12\u2009weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12\u2009weeks. Thirty\u2010eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.<\/jats:p>","DOI":"10.1111\/iwj.13598","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T09:34:57Z","timestamp":1620120897000},"page":"64-75","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis"],"prefix":"10.1111","volume":"19","author":[{"given":"David G.","family":"Armstrong","sequence":"first","affiliation":[{"name":"Department of Surgery University of Southern California, Keck School of Medicine  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis P.","family":"Orgill","sequence":"additional","affiliation":[{"name":"Division of Plastic Surgery Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Galiano","sequence":"additional","affiliation":[{"name":"Division of Plastic Surgery Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul M.","family":"Glat","sequence":"additional","affiliation":[{"name":"Drexel University  Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence","family":"Didomenico","sequence":"additional","affiliation":[{"name":"Lower Extremity Institute of Research and Therapy  Youngstown Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Reyzelman","sequence":"additional","affiliation":[{"name":"Center for Clinical Research  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Snyder","sequence":"additional","affiliation":[{"name":"Clinical Research Barry University SPM, Brand Research Center, Barry University  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William W.","family":"Li","sequence":"additional","affiliation":[{"name":"The Angiogenesis Foundation  Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marissa","family":"Carter","sequence":"additional","affiliation":[{"name":"Strategic Solutions  Bozeman Montana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5682-7056","authenticated-orcid":false,"given":"Charles M.","family":"Zelen","sequence":"additional","affiliation":[{"name":"Department of Medical Education The Professional Education and Research Institute (PERI)  Roanoke Virginia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,4]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.07.007"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.7547\/1000335"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1615439"},{"key":"e_1_2_8_5_1","unstructured":"U.S. Department of Health and Human Services.Centers for Disease Control and Prevention. 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