{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T15:40:17Z","timestamp":1777045217765,"version":"3.51.4"},"reference-count":45,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,8,3]],"date-time":"2016-08-03T00:00:00Z","timestamp":1470182400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007075","name":"Osiris Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007075","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":[[2017,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Complex diabetic foot ulcers (<jats:styled-content style=\"fixed-case\">DFUs<\/jats:styled-content>) with exposed tendon or bone remain a challenge. They are more susceptible to complications such as infection and amputation and require treatments that promote rapid development of granulation tissue and, ultimately, reepithelialisation. The clinical effectiveness of viable cryopreserved human placental membrane (<jats:styled-content style=\"fixed-case\">vCHPM<\/jats:styled-content>) for <jats:styled-content style=\"fixed-case\">DFUs<\/jats:styled-content> has been established in a level 1 trial. However, complex wounds with exposed deeper structures are typically excluded from randomised controlled clinical trials despite being common in clinical practice. We report the results of a prospective, multicentre, open\u2010label, single\u2010arm clinical trial to establish clinical outcomes when <jats:styled-content style=\"fixed-case\">vCHPM<\/jats:styled-content> is applied weekly to complex <jats:styled-content style=\"fixed-case\">DFUs<\/jats:styled-content> with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex <jats:styled-content style=\"fixed-case\">DFU<\/jats:styled-content> extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and\/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14\u00b76 cm<jats:sup>2<\/jats:sup>, and mean duration was 7\u00b75 months. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96\u00b73% of patients in a mean of 6\u00b78 weeks. Complete wound closure occurred in 59\u00b73% (mean 9\u00b71 weeks). The 4\u2010week percent area reduction was 54\u00b73%. There were no product\u2010related adverse events. Four patients (13%) withdrew, two (6\u00b75%) for non\u2010compliance and two (6\u00b75%) for surgical intervention.<\/jats:p>","DOI":"10.1111\/iwj.12649","type":"journal-article","created":{"date-parts":[[2016,8,4]],"date-time":"2016-08-04T00:17:09Z","timestamp":1470269829000},"page":"569-577","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["A prospective, multicentre, open\u2010label, single\u2010arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and\/or bone: positive clinical outcomes of viable cryopreserved human placental membrane"],"prefix":"10.1111","volume":"14","author":[{"given":"Robert G","family":"Frykberg","sequence":"first","affiliation":[{"name":"Department of Podiatry Carl T. Hayden VA Medical Center  Phoenix AZ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary W","family":"Gibbons","sequence":"additional","affiliation":[{"name":"Center for Wound Healing South Shore Hospital  Weymouth MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jodi L","family":"Walters","sequence":"additional","affiliation":[{"name":"Department of Podiatry Southern Arizona VA Health Care System  Tucson AZ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dane K","family":"Wukich","sequence":"additional","affiliation":[{"name":"UPMC Wound Healing Services UPMC Mercy  Pittsburgh PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farrell C","family":"Milstein","sequence":"additional","affiliation":[{"name":"Osiris Therapeutics, Inc  Columbia MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,8,3]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Centers for Disease Control and Prevention.National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States 2014. 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