{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T17:26:13Z","timestamp":1793726773736,"version":"4.6.1"},"reference-count":75,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T00:00:00Z","timestamp":1764806400000},"content-version":"vor","delay-in-days":33,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Wound Repair Regeneration"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    TTAX01\/Neox 1K are cryopreserved ultra\u2010thick human amniotic membrane products derived from umbilical cord (cUC) that have been assessed for clinical effectiveness in complex diabetic foot ulcers (DFUs). Herein, a randomised controlled trial was conducted to assess the safety and efficacy of cUC versus standard of care (SOC) for DFUs with exposed bone, tendon, muscle and\/or joint capsule and controlled osteomyelitis. A total of 220 eligible patients were enrolled and randomised to receive cUC\u2009+\u2009SOC (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009118) or SOC alone (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009102), which included debridement, bone resection, wound dressings, offloading and a 6\u2010week course of systemic antibiotics. cUC was applied at baseline and reapplied at a minimum of 4\u2010week intervals if healing was stalled throughout a 16\u2010week treatment period, for a maximum of four applications. The mean baseline wound area for the cUC and SOC groups was 5.64\u2009\u00b1\u20095.5\u2009cm\n                    <jats:sup>2<\/jats:sup>\n                    and 5.30\u2009\u00b1\u20094.6\u2009cm\n                    <jats:sup>2<\/jats:sup>\n                    , respectively. By 26\u2009weeks, 139 patients achieved complete healing in the intent\u2010to\u2010treat population (66.1% cUC group vs. 59.8% SOC group;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.40). An average of 1.67\u2009\u00b1\u20090.87 applications were required to achieve wound closure in the cUC group. By 50\u2009weeks, 77.1% of patients treated with cUC achieved complete healing compared to 71.6% in the SOC group (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.29). Adverse event rates, i.e., 89.8% and 87.3%, were comparable between cUC and SOC groups. While there were no significant differences in healing rates or adverse events between the two treatment arms at any time point, this study demonstrates that adjunctive cUC is safe and helps achieve a high healing rate at 50\u2009weeks with less than four applications for complex DFUs that are often excluded in clinical trials.\n                  <\/jats:p>","DOI":"10.1111\/wrr.70110","type":"journal-article","created":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T06:51:38Z","timestamp":1764917498000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Multi\u2010Centre, Randomised, Controlled Clinical Trial Assessing Cryopreserved Ultra\u2010Thick Human Amniotic Membrane in the Treatment of Complex Diabetic Foot Ulcers"],"prefix":"10.1111","volume":"33","author":[{"given":"Joseph","family":"Caporusso","sequence":"first","affiliation":[{"name":"Futuro Clinical Trials  McAllen Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Travis","family":"Motley","sequence":"additional","affiliation":[{"name":"Acclaim Physician Group John Peter Smith Hospital  Fort Worth Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"II","given":"John C.","family":"Lantis","sequence":"additional","affiliation":[{"name":"Department of Surgery Icahn School of Medicine  New York New York USA"},{"name":"Department of Surgery Mount Sinai West Hospital  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Heisler","sequence":"additional","affiliation":[{"name":"Department of Surgery University of North Carolina School of Medicine  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Hicks","sequence":"additional","affiliation":[{"name":"Podiatric Medicine and Surgery, Department of Orthopaedic Surgery Vanderbilt University Medical Center  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie C.","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Podiatric Surgery and Applied Biomechanics and Center for Stem Cell and Regenerative Medicine William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of Medicine and Science  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Reyzelman","sequence":"additional","affiliation":[{"name":"College of Podiatric Medicine, Samuel Merritt University  Oakland California USA"},{"name":"Center for Limb Preservation and Diabetic Foot, Division of Vascular and Endovascular Surgery University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.2147\/DMSO.S256243"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.1994.tb00310.x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc07-1302"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cis346"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1992.00400150120022"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.6.951"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.3.382"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-020-00383-2"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12404"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dsx.2017.04.008"},{"issue":"1","key":"e_1_2_9_12_1","first-page":"1","article-title":"Cost and Mortality Data of a Regional Limb Salvage and Hyperbaric Medicine Program for Wagner Grade 3 or 4 Diabetic Foot Ulcers","volume":"43","author":"Eggert J. V.","year":"2016","journal-title":"Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2017.26.7.361"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.216"},{"key":"e_1_2_9_15_1","volume-title":"National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States","author":"CDC","year":"2014"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2013.08.003"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12642"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.13190"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/ans.15351"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2011.10.034"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.3165"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-019-0345-y"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2015.11.025"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2245"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2017.0743"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.25.10.1835"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1586\/eop.10.63"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-4632.2009.04173.x"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1542-0124(12)70059-9"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.15-17637"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tice.2024.102535"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M109.021881"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.13-13094"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.08-1781"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M113.479584"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200103000-00019"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M409567200"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1038\/srep42195"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-4652(199906)179:3<325::AID-JCP10>3.0.CO;2-X"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.61.5.62"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2014.23.10.465"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12456"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2017.26.Sup10.S38"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12754"},{"key":"e_1_2_9_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.10.003"},{"issue":"5","key":"e_1_2_9_46_1","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/S1067-2516(07)60001-5","article-title":"Diabetic Foot Disorders. A Clinical Practice Guideline (2006 Revision)","volume":"45","author":"Frykberg R. G.","year":"2006","journal-title":"Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-025-03635-5"},{"key":"e_1_2_9_48_1","doi-asserted-by":"publisher","DOI":"10.2217\/cer-2019-0142"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12954"},{"issue":"3","key":"e_1_2_9_50_1","first-page":"70","article-title":"A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer","volume":"28","author":"Snyder R. 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Wound Repair and Regeneration: Official Publication of the Wound Healing Society [and] the European Tissue Repair","volume":"26","author":"Ananian C. 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