{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T15:54:18Z","timestamp":1788278058945,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,8,27]],"date-time":"2018-08-27T00:00:00Z","timestamp":1535328000000},"content-version":"vor","delay-in-days":118,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/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":["Wound Repair Regeneration"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Randomized controlled clinical trials, the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers in comparison to standard of care. However, randomized controlled clinical trials comparing efficacy between two or more skin substitutes are very limited. With growing numbers of new skin substitutes, such studies are essential for treatment and policy\u2010making decisions by wound care providers and payers. In this study, we analyzed clinical outcomes and product cost between a viable cryopreserved placental membrane (vCPM) and a human fibroblast\u2010derived dermal substitute (hFDS) for the treatment of chronic diabetic foot ulcers in a prospective, multicenter, single\u2010blind study. The outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group and 31 patients in the hFDS treatment group. Utilizing a non\u2010inferiority trial design and the established treatment regimen of 8 applications for hFDS, we demonstrated that vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% CI: [10.67, 28.94]). However, preliminary findings show that vCPM may have better outcomes for wounds\u2009\u2264\u20095 cm<jats:sup>2<\/jats:sup>: 81.3% (13\/16) of wounds in the vCPM group vs. 37.5% (6\/16) of wounds in the hFDS group reached complete closure at the end of treatment (<jats:italic>p<\/jats:italic>\u2009=\u20090.0118). A preliminary product cost analysis for wounds\u2009\u2264\u20095 cm<jats:sup>2<\/jats:sup> may show significant savings for patients treated with vCPM. Average per\u2010patient costs during the course of treatment were $3,846 and $7,968 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) for vCPM and hFDS patients, respectively. These results may be used as guidance to wound care providers and payers.<\/jats:p>","DOI":"10.1111\/wrr.12645","type":"journal-article","created":{"date-parts":[[2018,8,11]],"date-time":"2018-08-11T15:58:31Z","timestamp":1534003111000},"page":"274-283","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["A multicenter, randomized, single\u2010blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast\u2010derived dermal substitute for the treatment of chronic diabetic foot ulcers"],"prefix":"10.1111","volume":"26","author":[{"given":"Charles E.","family":"Ananian","sequence":"first","affiliation":[{"name":"New Hope Podiatry  Los Angeles California 90063 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yadwinder S.","family":"Dhillon","sequence":"additional","affiliation":[{"name":"Banner University Medical Center  Phoenix Arizona 85006 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl C.","family":"Van Gils","sequence":"additional","affiliation":[{"name":"Foot &amp; Ankle Institute  St. George Utah 84770 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Craig","family":"Lindsey","sequence":"additional","affiliation":[{"name":"CHRISTUS St. Vincent Regional Wound and Hyperbaric Center  Santa Fe New Mexico 87505 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond J.","family":"Otto","sequence":"additional","affiliation":[{"name":"St. Luke's Clinic \u2013 Wound and Hyperbarics  Meridian Idaho 83642 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyaandi R.","family":"Dove","sequence":"additional","affiliation":[{"name":"Advanced Foot &amp; Ankle Center  Las Vegas Nevada 89119 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica T.","family":"Pierce","sequence":"additional","affiliation":[{"name":"Virginia Mason Medical Center  Federal Way Washington 98003 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molly C.","family":"Saunders","sequence":"additional","affiliation":[{"name":"Osiris Therapeutics, Inc.  Columbia Maryland 21046 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,8,27]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"National diabetes statistics report: Estimates of diabetes and its burden in the United States, 2017","author":"Centers for Disease Control and Prevention","year":"2014"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.293.2.217"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2015.0635"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2013.06.055"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.10.003"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1056-8727(00)00133-1"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1262-3636(07)70193-3"},{"key":"e_1_2_8_9_1","volume-title":"Data points publication series [internet]","author":"Margolis DJ","year":"2011"},{"key":"e_1_2_8_10_1","unstructured":"U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health. Guidance for industry: chronic cutaneous ulcer and burn wounds \u2013 developing products for treatment.2006June.https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm071324.pdf. 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