{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T04:56:05Z","timestamp":1792299365722,"version":"4.4.0"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T00:00:00Z","timestamp":1588982400000},"content-version":"vor","delay-in-days":0,"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":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>An open label, multicenter 16\u2010week trial of cryopreserved human umbilical cord (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure following a median of one product application (previous study). All but two subjects (30\/32; 94%) consented to participate in this follow\u2010up study to 1\u2010year postexposure. No restrictions were placed on treatments for open wounds. At 8\u2010week intervals, subjects were evaluated for adverse events (AEs) and wound status (open or closed). Average time from initial exposure to end of follow\u2010up was 378\u2009days (range 343\u2010433), with 29 of 30 (97%) subjects completing a full year. AEs were all typical for the population under study, and none were attributed to prior exposure to TTAX01. One previously healed wound re\u2010opened, one previously unconfirmed closed wound remained healed, and nine new wound closures occurred, giving 25 of 29 (86.2%) healed in the ITT population. Three of the new closures followed the use of various tissue\u2010based products. Three subjects whose wounds were healed required subsequent minor amputations due to osteomyelitis, one of which progressed to a major amputation (1\/29; 3.4%). One additional subject underwent two minor amputations prior to healing. Overall, the study found TTAX01 to be safe in long\u2010term follow\u2010up and associated with both a low rate of major amputation and a higher than expected rates of healing.<\/jats:p>","DOI":"10.1111\/wrr.12809","type":"journal-article","created":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T18:09:14Z","timestamp":1589047754000},"page":"526-531","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["One\u2010year safety, healing and amputation rates of Wagner 3\u20104 diabetic foot ulcers treated with cryopreserved umbilical cord (<scp>TTAX01<\/scp>)"],"prefix":"10.1111","volume":"28","author":[{"given":"William A.","family":"Marston","sequence":"first","affiliation":[{"name":"Division of Vascular Surgery University of North Carolina School of Medicine  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"II","given":"John C.","family":"Lantis","sequence":"additional","affiliation":[{"name":"Mt Sinai West and St Luke's Hospitals  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie C.","family":"Wu","sequence":"additional","affiliation":[{"name":"Rosalind Franklin University  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9904-6065","authenticated-orcid":false,"given":"Aksone","family":"Nouvong","sequence":"additional","affiliation":[{"name":"Department of Surgery UCLA  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Randolph","family":"Clements","sequence":"additional","affiliation":[{"name":"Carilion Clinic  Roanoke Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommy D.","family":"Lee","sequence":"additional","affiliation":[{"name":"TissueTech, Inc.  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas D.","family":"McCoy","sequence":"additional","affiliation":[{"name":"TissueTech, Inc.  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0550-8757","authenticated-orcid":false,"given":"Herbert B.","family":"Slade","sequence":"additional","affiliation":[{"name":"TissueTech, Inc.  Miami Florida USA"},{"name":"Department of Pediatrics University of North Texas Health Sciences Center  Fort Worth Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scheffer C.","family":"Tseng","sequence":"additional","affiliation":[{"name":"TissueTech, Inc.  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,9]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12272-019-01130-3"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2006.01773.x"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-481X.2010.00745.x"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tem.2018.04.008"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.293.2.217"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1380"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2009.00543.x"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.wndm.2013.10.008"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12754"},{"key":"e_1_2_6_11_1","unstructured":"U. S. 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