{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T20:25:25Z","timestamp":1790886325269,"version":"4.1.0"},"reference-count":58,"publisher":"Mark Allen Group","issue":"Sup7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Wound Care"],"published-print":{"date-parts":[[2024,7,1]]},"abstract":"<jats:sec><jats:title>Objective:<\/jats:title><jats:p> Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population. <\/jats:p><\/jats:sec><jats:sec><jats:title>Method:<\/jats:title><jats:p> Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan\u2013Meier analysis was used to determine median time to complete wound closure (CWC). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to \u2018not achieved\u2019 in the SoC-treated group (i.e., \u226550% of SoC-treated DFUs failed to heal by week 12; p=0.04). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population. <\/jats:p><\/jats:sec><jats:sec><jats:title>Declaration of interest:<\/jats:title><jats:p> This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare. <\/jats:p><\/jats:sec>","DOI":"10.12968\/jowc.2024.0139","type":"journal-article","created":{"date-parts":[[2024,6,6]],"date-time":"2024-06-06T12:57:41Z","timestamp":1717678661000},"page":"S4-S14","source":"Crossref","is-referenced-by-count":14,"title":["Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial"],"prefix":"10.12968","volume":"33","author":[{"given":"Shawn M","family":"Cazzell","sequence":"first","affiliation":[{"name":"Limb Preservation Platform, Inc., Fresno, CA, US."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Caporusso","sequence":"additional","affiliation":[{"name":"Futuro Clinical Trials, McAllen, TX, US."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Vayser","sequence":"additional","affiliation":[{"name":"ILD Research Center, Vista, CA, US."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R Daniel","family":"Davis","sequence":"additional","affiliation":[{"name":"St. Vincent's Medical Center, Bridgeport, CT, US."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oscar M","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Department of Surgery, Division of Plastic Surgery, Rutgers NJMS, Newark, NJ, US."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L","family":"Sabolinski","sequence":"additional","affiliation":[{"name":"Sabolinski LLC, Franklin, MA, US."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"5130","reference":[{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1002\/dme.1996.13.s1.6"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2625"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1001\/jama.293.2.217"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.5.692"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000016877"},{"key":"B7","volume-title":"Data Points Publication Series [Internet]","author":"Margolis DJ","year":"2011"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.2217\/cer-2019-0142"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2018.10.005"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2015.0635"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1111\/nyas.13569"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1186\/s12902-016-0111-0"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.4239\/wjd.v7.i7.153"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-481X.2007.00392.x"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1016\/j.dsx.2016.06.023"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1177\/2042018817744513"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2176"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2015.1031793"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2014.05.009"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-016-0329-y"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.2337\/db20182-1"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.13133"},{"issue":"6","key":"B23","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1111\/wrr.12357","volume":"33","author":"Driver VR","year":"2015","journal-title":"Wound Repair Regen"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12329"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2015.0645"},{"issue":"5","key":"B26","first-page":"33A","volume":"12","author":"Sabolinski ML","year":"2000","journal-title":"Wounds: a Compendium of Clinical Research and Practice"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1097\/GOX.0000000000001095"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.22203\/eCM.v015a07"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12748"},{"key":"B30","doi-asserted-by":"publisher","DOI":"10.1002\/term.2876"},{"key":"B31","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.13103"},{"key":"B32","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12757"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12140"},{"issue":"1","key":"B35","first-page":"20","volume":"33","author":"Koullias GJ","year":"2021","journal-title":"Wounds"},{"issue":"4","key":"B36","first-page":"S19","volume":"31","author":"Caporusso J","year":"2019","journal-title":"Wounds"},{"key":"B37","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.10.003"},{"key":"B38","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-015-0687-5"},{"key":"B39","doi-asserted-by":"publisher","DOI":"10.6064\/2012\/435487"},{"issue":"3","key":"B40","doi-asserted-by":"crossref","first-page":"179S","DOI":"10.1097\/PRS.0000000000002686","volume":"138","author":"Bus SA","year":"2016","journal-title":"Plast Reconstr Surg"},{"key":"B41","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.6.1701"},{"key":"B42","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.24.2.290"},{"issue":"3","key":"B43","first-page":"70","volume":"28","author":"Snyder RJ","year":"2016","journal-title":"Wounds"},{"key":"B44","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.14017"},{"key":"B45","doi-asserted-by":"publisher","DOI":"10.1001\/archderm.134.3.293"},{"key":"B46","doi-asserted-by":"publisher","DOI":"10.25270\/wnds\/20174"},{"key":"B47","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2024.33.Sup3.S16"},{"issue":"5","key":"B48","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1111\/wrr.12332","volume":"33","author":"Kirsner RS","year":"2015","journal-title":"Wound Repair Regen"},{"key":"B49","doi-asserted-by":"publisher","DOI":"10.2217\/cer-2018-0031"},{"key":"B50","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12156"},{"issue":"6","key":"B51","first-page":"E36","volume":"29","author":"McQuilling JP","year":"2017","journal-title":"Wounds"},{"key":"B52","doi-asserted-by":"publisher","DOI":"10.1002\/jor.24173"},{"issue":"6","key":"B53","first-page":"S1","volume":"28","author":"Carpenter S","year":"2016","journal-title":"Wounds"},{"key":"B54","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2010.19.2.46966"},{"key":"B55","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-017-0298-8"},{"key":"B56","doi-asserted-by":"publisher","DOI":"10.1097\/GOX.0000000000001302"},{"issue":"1","key":"B57","first-page":"10","volume":"24","author":"Fife CE","year":"2012","journal-title":"Wounds"},{"key":"B58","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.07.007"},{"key":"B59","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2013.1324"},{"key":"B60","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000194"}],"container-title":["Journal of Wound Care"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.magonlinelibrary.com\/doi\/pdf\/10.12968\/jowc.2024.0139","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T10:16:40Z","timestamp":1720433800000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.magonlinelibrary.com\/doi\/10.12968\/jowc.2024.0139"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,1]]},"references-count":58,"journal-issue":{"issue":"Sup7","published-print":{"date-parts":[[2024,7,1]]}},"alternative-id":["10.12968\/jowc.2024.0139"],"URL":"https:\/\/doi.org\/10.12968\/jowc.2024.0139","relation":{},"ISSN":["0969-0700","2052-2916"],"issn-type":[{"value":"0969-0700","type":"print"},{"value":"2052-2916","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,1]]}}}