{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T02:11:39Z","timestamp":1791598299446,"version":"4.3.4"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,9,24]],"date-time":"2018-09-24T00:00:00Z","timestamp":1537747200000},"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                    The aim of this study was to determine the safety and effectiveness of dehydrated human umbilical cord allograft (EpiCord) compared with alginate wound dressings for the treatment of chronic, non\u2010healing diabetic foot ulcers (DFU). A multicentre, randomised, controlled, clinical trial was conducted at 11 centres in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2 diabetes presenting with a 1 to 15\u2009cm\n                    <jats:sup>2<\/jats:sup>\n                    ulcer located below the ankle that had been persisting for at least 30\u2009days were eligible for the 14\u2010day study run\u2010in phase. After 14\u2009days of weekly debridement, moist wound therapy, and off\u2010loading, those with \u226430% wound area reduction post\u2010debridement (n\u2009=\u2009155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n\u2009=\u2009101) or standardised therapy with alginate wound dressing, non\u2010adherent silicone dressing, absorbent non\u2010adhesive hydropolymer secondary dressing, and gauze bandage roll (n\u2009=\u200954). All wounds continued to have appropriate off\u2010loading during the treatment phase of the study. Study visits were conducted for 12\u2009weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre\u2010 and post\u2010debridement and measured before the application of treatment group\u2010specific dressings. A follow\u2010up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12\u2009weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent\u2010to\u2010treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n\u2009=\u2009134) who completed the study per protocol (PP) (EpiCord, n\u2009=\u200986, alginate, n\u2009=\u200948) and for those subjects receiving adequate debridement (EpiCord, n\u2009=\u200967, alginate, n\u2009=\u200940). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12\u2009weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively,\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0089. Healing rates at 12\u2009weeks for subjects treated PP were 70 of 86 (81%) for EpiCord\u2010treated and 26 of 48 (54%) for alginate\u2010treated DFUs,\n                    <jats:italic>P<\/jats:italic>\n                    = 0.0013. For those DFUs that received adequate debridement (n\u2009=\u2009107, ITT population), 64 of 67 (96%) of the EpiCord\u2010treated ulcers healed completely within 12\u2009weeks, compared with 26 of 40 (65%) of adequately debrided alginate\u2010treated ulcers,\n                    <jats:italic>P<\/jats:italic>\n                    &lt; 0.0001. Seventy\u2010five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non\u2010healing DFUs.\n                  <\/jats:p>","DOI":"10.1111\/iwj.13001","type":"journal-article","created":{"date-parts":[[2018,9,24]],"date-time":"2018-09-24T06:00:06Z","timestamp":1537768806000},"page":"122-130","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":83,"title":["A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers"],"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":"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 McAllen  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"}]},{"given":"Jason","family":"Hanft","sequence":"additional","affiliation":[{"name":"Miami Foot and Ankle  Miami Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyaandi","family":"Dove","sequence":"additional","affiliation":[{"name":"Advanced Foot &amp; Ankle Center  Las Vegas Nevada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,9,24]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Centers for Disease Control and PreventionNational Diabetes Statistics Report 2017. Atlanta GA: Centers for Disease Control and Prevention U.S. Department of Health and Human Services;2017.https:\/\/www.cdc.gov\/diabetes\/pdfs\/data\/statistics\/national-diabetes-statistics-report.pdf. 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Diabetic Ulcer Study Group","volume":"183","author":"Steed DL","year":"1996","journal-title":"J Am Coll Surg"},{"key":"e_1_2_6_23_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.13001","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.13001","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/iwj.13001","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.13001","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T10:35:47Z","timestamp":1694342147000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iwj.13001"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,24]]},"references-count":22,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1111\/iwj.13001"],"URL":"https:\/\/doi.org\/10.1111\/iwj.13001","archive":["Portico"],"relation":{},"ISSN":["1742-4801","1742-481X"],"issn-type":[{"value":"1742-4801","type":"print"},{"value":"1742-481X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,9,24]]},"assertion":[{"value":"2018-06-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-31","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}