{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T02:11:31Z","timestamp":1791598291003,"version":"4.3.4"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,8,22]],"date-time":"2018-08-22T00:00:00Z","timestamp":1534896000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"MiMedx Group, Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:p>\n                    A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the United States to confirm the efficacy of dehydrated human amnion\/chorion membrane allograft (dHACM) for the treatment of chronic lower extremity ulcers in persons with diabetes. Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2\u2010week study run\u2010in phase and treated with alginate wound dressings and appropriate offloading. Those with less than or equal to 25% wound closure after run\u2010in were randomly assigned to receive weekly dHACM application in addition to offloading or standard of care with alginate wound dressings, for 12\u2009weeks. A total of 110 patients were included in the intent\u2010to\u2010treat (ITT) analysis, with\n                    <jats:italic>n<\/jats:italic>\n                    =\u200954 in the dHACM group and\n                    <jats:italic>n<\/jats:italic>\n                    =\u200956 in the no\u2010dHACM group. Of the participants, 98 completed the study per protocol, with 47 receiving dHACM and 51 not receiving dHACM. The primary study outcome was percentage of study ulcers completely healed in 12\u2009weeks, with both ITT and per\u2010protocol participants receiving weekly dHACM significantly more likely to completely heal than those not receiving dHACM (ITT\u201470% versus 50%,\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0338, per\u2010protocol\u201481% versus 55%,\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0093). A Kaplan\u2013Meier analysis was performed to compare the time\u2010to\u2010healing performance with\/without dHACM, showing a significantly improved time to healing with the use of allograft, log\u2010rank\n                    <jats:italic>P<\/jats:italic>\n                    &lt; 0.0187. Cox regression analysis showed that dHACM\u2010treated subjects were more than twice as likely to heal completely within 12\u2009weeks than no\u2010dHACM subjects (HR: 2.15, 95% confidence interval 1.30\u20133.57,\n                    <jats:italic>P<\/jats:italic>\n                    = 0.003). At the final follow up at 16\u2009weeks, 95% of dHACM\u2010healed ulcers and 86% of healed ulcers in the no\u2010dHACM group remained closed. These results confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population.\n                  <\/jats:p>","DOI":"10.1111\/iwj.12976","type":"journal-article","created":{"date-parts":[[2018,8,22]],"date-time":"2018-08-22T22:45:14Z","timestamp":1534977914000},"page":"19-29","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":127,"title":["A confirmatory study on the efficacy of dehydrated human amnion\/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics"],"prefix":"10.1111","volume":"16","author":[{"given":"William","family":"Tettelbach","sequence":"first","affiliation":[{"name":"Wound Care &amp; Hyperbaric Medicine Clinical Services Intermountain Healthcare  Salt Lake City Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn","family":"Cazzell","sequence":"additional","affiliation":[{"name":"Limb Preservation Platform, Inc.  Fresno California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander M","family":"Reyzelman","sequence":"additional","affiliation":[{"name":"Center for Clinical Research, Inc.  San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Sigal","sequence":"additional","affiliation":[{"name":"Foot and Ankle Clinic  Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph M","family":"Caporusso","sequence":"additional","affiliation":[{"name":"Futuro Clinical Trials  Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick S","family":"Agnew","sequence":"additional","affiliation":[{"name":"Coastal Podiatry, Inc.  Virginia Beach Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,8,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/diaclin.24.2.91"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2009.10.007"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2625"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1615439"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-159-8-201310150-00006"},{"issue":"1","key":"e_1_2_8_7_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"},{"issue":"3","key":"e_1_2_8_8_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 Manag"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2006.00176.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12097"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12395"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12566"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0022034509359125"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2011.00673.x"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12140"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.b.33141"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/2045-824X-6-10"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI29710"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jss.2014.08.045"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyh299"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/1748-5908-2-42"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2013.4960"},{"issue":"1","key":"e_1_2_8_23_1","first-page":"61","article-title":"Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic ulcer study group","volume":"183","author":"Steed DL","year":"1996","journal-title":"J Am Coll Surg"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.2119\/2006-00054.Brem"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/GOX.0000000000001302"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2014.05.009"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.83221"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.5.692"}],"container-title":["International Wound Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fiwj.12976","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.12976","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/iwj.12976","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.12976","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T10:35:44Z","timestamp":1694342144000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iwj.12976"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,22]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1111\/iwj.12976"],"URL":"https:\/\/doi.org\/10.1111\/iwj.12976","archive":["Portico"],"relation":{},"ISSN":["1742-4801","1742-481X"],"issn-type":[{"value":"1742-4801","type":"print"},{"value":"1742-481X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,22]]},"assertion":[{"value":"2018-04-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-07-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-22","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}