{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T01:10:20Z","timestamp":1788570620874,"version":"build-2803163510"},"reference-count":51,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,6,12]],"date-time":"2017-06-12T00:00:00Z","timestamp":1497225600000},"content-version":"vor","delay-in-days":42,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"LifeNet Health"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Wound Repair Regeneration"],"published-print":{"date-parts":[[2017,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study compared the efficacy and safety of a human acellular dermal matrix (ADM), D\u2010ADM, with a conventional care arm and an active comparator human ADM arm, GJ\u2010ADM, for the treatment of chronic diabetic foot ulcers. The study design was a prospective, randomized controlled trial that enrolled 168 diabetic foot ulcer subjects in 13 centers across 9 states. Subjects in the ADM arms received one application but could receive one additional application of ADM if deemed necessary. Screen failures and early withdrawals left 53 subjects in the D\u2010ADM arm, 56 in the conventional care arm, and 23 in the GJ\u2010ADM arm (2:2:1 ratio). Subjects were followed through 24 weeks with major endpoints at Weeks 12, 16, and 24. Single application D\u2010ADM subjects showed significantly greater wound closure rates than conventional care at all three endpoints while all applications D\u2010ADM displayed a significantly higher healing rate than conventional care at Week 16 and Week 24. GJ\u2010ADM did not show a significantly greater healing rate over conventional care at any of these time points. A blinded, third party adjudicator analyzed healing at Week 12 and expressed \u201cstrong\u201d agreement (\u03ba\u2009=\u20090.837). Closed ulcers in the single application D\u2010ADM arm remained healed at a significantly greater rate than the conventional care arm at 4 weeks posttermination (100% vs. 86.7%; <jats:italic>p<\/jats:italic>\u2009=\u20090.0435). There was no significant difference between GJ\u2010ADM and conventional care for healed wounds remaining closed. Single application D\u2010ADM demonstrated significantly greater average percent wound area reduction than conventional care for Weeks 2\u201324 while single application GJ\u2010ADM showed significantly greater wound area reduction over conventional care for Weeks 4\u20136, 9, and 11\u201312. D\u2010ADM demonstrated significantly greater wound healing, larger wound area reduction, and a better capability of keeping healed wounds closed than conventional care in the treatment of chronic DFUs.<\/jats:p>","DOI":"10.1111\/wrr.12551","type":"journal-article","created":{"date-parts":[[2017,5,25]],"date-time":"2017-05-25T16:59:12Z","timestamp":1495731552000},"page":"483-497","source":"Crossref","is-referenced-by-count":70,"title":["A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator"],"prefix":"10.1111","volume":"25","author":[{"given":"Shawn","family":"Cazzell","sequence":"first","affiliation":[{"name":"Limb Preservation Platform Valley Vascular Surgical Associates Fresno California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Vayser","sequence":"additional","affiliation":[{"name":"ILD Research Center San Diego California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hau","family":"Pham","sequence":"additional","affiliation":[{"name":"Boston Medical Center Boston University School of Medicine Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodi","family":"Walters","sequence":"additional","affiliation":[{"name":"Southern Arizona VA Health Care System Tucson Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Reyzelman","sequence":"additional","affiliation":[{"name":"UCSF Center for Limb Preservation California School of Podiatric Medicine at Samuel Merritt University San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Samsell","sequence":"additional","affiliation":[{"name":"LifeNet Health Virginia Beach Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Dorsch","sequence":"additional","affiliation":[{"name":"LifeNet Health Virginia Beach Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Moore","sequence":"additional","affiliation":[{"name":"LifeNet Health Virginia Beach Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,6,12]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"National diabetes statistics report: estimates of diabetes and its burden in the United States","author":"CDC","year":"2014"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2013.11.002"},{"key":"e_1_2_6_4_1","first-page":"120","article-title":"Diabetes and foot care: time to act","volume":"8","author":"Bakker K","year":"2005","journal-title":"Diabetic Foot J"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2168.2000.01344.x"},{"key":"e_1_2_6_6_1","first-page":"875","article-title":"Limb amputation and limb deficiency: epidemiology and recent trends in the United States","volume":"95","author":"Dillingham TR","year":"2002","journal-title":"South Med J"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2254"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67675-1"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.293.2.217"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67698-2"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/dme.1996.13.s1.6"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2016.01.003"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2704"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2009.00543.x"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2176"},{"key":"e_1_2_6_16_1","first-page":"e10","article-title":"Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full\u2010thickness diabetic foot ulcers","volume":"16","author":"Walters J","year":"2016","journal-title":"Eplasty"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-481X.2009.00585.x"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12357"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10561-014-9467-4"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-540-77755-7_50"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/918753"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/SAP.0b013e31823b6b01"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2011.01.057"},{"key":"e_1_2_6_24_1","unstructured":"United States Pharmacopeia (USP). 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