{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T15:18:42Z","timestamp":1790954322353,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,1,9]],"date-time":"2022-01-09T00:00:00Z","timestamp":1641686400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100019921","name":"Geistlich Pharma","doi-asserted-by":"publisher","award":["002"],"award-info":[{"award-number":["002"]}],"id":[{"id":"10.13039\/501100019921","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from a pilot study using a novel purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot ulcers (DFUs), we designed a prospective, multi\u2010centre randomised trial comparing outcomes of PRBM at 12\u2009weeks compared with a standard of care (SOC) using a collagen alginate dressing. The primary endpoint was percentage of wounds closed after 12\u2009weeks. Secondary outcomes included assessments of complications, healing time, quality of life, and cost to closure. Forty patients were included in an intent\u2010to\u2010treat (ITT) and per\u2010protocol (PP) analysis, with 39 completing the study protocol (n\u00a0=\u00a019 PRBM, n\u00a0=\u00a020 SOC). Wounds treated with PRBM were significantly more likely to close than wounds treated with SOC (ITT: 85% vs 30%, <jats:italic>P<\/jats:italic>\u00a0=\u2009.0004, PP: 94% vs 30% <jats:italic>P<\/jats:italic>\u00a0=\u2009.00008), healed significantly faster (mean 37\u2009days vs 67\u2009days for SOC, <jats:italic>P<\/jats:italic>\u00a0=\u2009.002), and achieved a mean wound area reduction within 12\u2009weeks of 96% vs 8.9% for SOC. No adverse events (AEs) directly related to PRBM treatment were reported. Mean PRBM cost of healing was $1731. Use of PRBM was safe and effective for treatment of chronic DFUs.<\/jats:p>","DOI":"10.1111\/iwj.13715","type":"journal-article","created":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T05:03:17Z","timestamp":1641790997000},"page":"1197-1209","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled <scp>multi\u2010centre<\/scp> clinical trial"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1887-9175","authenticated-orcid":false,"given":"David G.","family":"Armstrong","sequence":"first","affiliation":[{"name":"Division of Surgery, Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8279-7310","authenticated-orcid":false,"given":"Dennis P.","family":"Orgill","sequence":"additional","affiliation":[{"name":"Professional Education and Research Institute  Roanoke Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9552-6483","authenticated-orcid":false,"given":"Robert D.","family":"Galiano","sequence":"additional","affiliation":[{"name":"Division of Plastic Surgery, Feinberg School of Medicine Northwestern University  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5009-8603","authenticated-orcid":false,"given":"Paul M.","family":"Glat","sequence":"additional","affiliation":[{"name":"Surgery and Pediatrics Drexel University College of Medicine, St. Christopher's Hospital for Children  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7967-8612","authenticated-orcid":false,"given":"Jarrod P.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Department of Surgery, Temple University School of Medicine and McGowan Institute for Regenerative Medicine University of Pittsburgh  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2265-6639","authenticated-orcid":false,"given":"Marissa J.","family":"Carter","sequence":"additional","affiliation":[{"name":"Strategic Solutions, Inc.  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