{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T02:11:33Z","timestamp":1791598293710,"version":"4.3.4"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2014,11,26]],"date-time":"2014-11-26T00:00:00Z","timestamp":1416960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"funder":[{"name":"MiMedx Group, Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    A prospective, randomised, controlled, parallel group, multi\u2010centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf\n                    <jats:sup>\u00ae<\/jats:sup>\n                    (Organogenesis, Inc., Canton,\n                    <jats:styled-content style=\"fixed-case\">MA<\/jats:styled-content>\n                    ),\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    <jats:sup>\u00ae<\/jats:sup>\n                    (\n                    <jats:styled-content style=\"fixed-case\">MiMedx<\/jats:styled-content>\n                    Group, Inc., Marietta,\n                    <jats:styled-content style=\"fixed-case\">GA<\/jats:styled-content>\n                    ), or standard wound care with collagen\u2010alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or\n                    <jats:styled-content style=\"fixed-case\">EpiFix used<\/jats:styled-content>\n                    . A total of 65 subjects entered the 2\u2010week run\u2010in period and 60 were randomised (20 per group). The proportion of patients in the\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    group achieving complete wound closure within 4 and 6 weeks was 85% and 95%, significantly higher (all adjusted\n                    <jats:italic>P<\/jats:italic>\n                    \u2010values \u2264 0\u00b7003) than for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%). After 1 week, wounds treated with\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    had reduced in area by 83\u00b75% compared with 53\u00b71% for wounds treated with Apligraf. Median time to healing was significantly faster (all adjusted\n                    <jats:italic>P<\/jats:italic>\n                    \u2010values \u22640\u00b7001) with\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    (13 days) compared to Apligraf (49 days) or standard care (49 days). The mean number of grafts used and the graft cost per patient were lower in the\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    group campared to the Apligraf group, at 2\u00b715 grafts at a cost of $1669 versus 6\u00b72 grafts at a cost of $9216, respectively. The results of this study demonstrate the clinical and resource utilisation superiority of\n                    <jats:styled-content style=\"fixed-case\">EpiFix<\/jats:styled-content>\n                    compared to Apligraf or standard of care, for the treatment of diabetic ulcers of the lower extremities.\n                  <\/jats:p>","DOI":"10.1111\/iwj.12395","type":"journal-article","created":{"date-parts":[[2014,11,26]],"date-time":"2014-11-26T03:17:18Z","timestamp":1416971838000},"page":"724-732","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":165,"title":["A prospective, randomised, controlled, multi\u2010centre comparative effectiveness study of healing using dehydrated human amnion\/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers"],"prefix":"10.1111","volume":"12","author":[{"given":"Charles M","family":"Zelen","sequence":"first","affiliation":[{"name":"Professional Education and Research Institute  Roanoke VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5167-4679","authenticated-orcid":false,"given":"Lisa","family":"Gould","sequence":"additional","affiliation":[{"name":"Wound Recovery Center Kent Hospital  Warwick RI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas E","family":"Serena","sequence":"additional","affiliation":[{"name":"Serena Group  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marissa J","family":"Carter","sequence":"additional","affiliation":[{"name":"Strategic Solutions, Inc.  Cody WY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Keller","sequence":"additional","affiliation":[{"name":"Shenandoah Lower Extremity Research  Daleville VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William W","family":"Li","sequence":"additional","affiliation":[{"name":"The Angiogenesis Foundation  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,11,26]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2009.10.007"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2625"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc08-9021"},{"key":"e_1_2_6_5_1","first-page":"13","article-title":"Health economic implications for wound care and limb preservation","volume":"11","author":"Driver VR","year":"2008","journal-title":"J Manag Care Med"},{"key":"e_1_2_6_6_1","first-page":"197","article-title":"Wound percent area reduction and making decisions about utilizing advanced therapies","volume":"29","author":"Snyder R","year":"2010","journal-title":"Podiatry Manage"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2006.00176.x"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0891-8422(02)00018-6"},{"key":"e_1_2_6_9_1","unstructured":"HoC TranK HuxM SibbaldG CampbellK.Artificial skin grafts in chronic wound care: a meta\u2010analysis of clinical efficacy and a review of cost\u2010effectiveness[Tech. 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