{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T05:22:08Z","timestamp":1787808128815,"version":"build-2784847793"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T00:00:00Z","timestamp":1784073600000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01DK119100"],"award-info":[{"award-number":["U01DK119100"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01DK119083"],"award-info":[{"award-number":["U01DK119083"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01DK119094"],"award-info":[{"award-number":["U01DK119094"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01DK119099"],"award-info":[{"award-number":["U01DK119099"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U24DK122927"],"award-info":[{"award-number":["U24DK122927"]}],"id":[{"id":"10.13039\/100000062","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":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Diabetic foot ulcers (DFUs) are the leading cause of amputations in people with diabetes, mainly due to poor wound healing. This study evaluated DFU trial designs and analysed observational data from the two prospective Diabetic Foot Consortium (DFC) studies to estimate longitudinal healing and amputation rates, assess the effects of wound surface area and duration on healing, and inform sample size considerations for future trials. We analysed data from Open Wound Master Protocol (MP,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009419) and c\u2010Myc Biomarker (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009140). The primary outcome was complete wound healing. Time\u2010to\u2010event analysis estimated healing and amputation rates, with amputations classified as non\u2010healed. Logistic regression assessed the prediction of healing based on baseline wound characteristics, with model performance evaluated using AUC (area under the curve). Sample size calculations were performed to achieve 80% power. In the MP study, healing rates were 26% by week 12% and 49% by week 32; amputation rates were 4% and 10%, respectively. The c\u2010Myc study showed 38% healing and 2.5% amputation by week 12. Wound area and duration significantly predicted healing (AUC \u2265\u20090.70 by 24\u2009weeks). For smaller treatment effects, predicted healing rates varied by up to 40% between small and large wounds, impacting sample size. Contemporary DFU trial designs and healing times remained largely unchanged over two decades. While shorter trials (e.g., 12\u2009weeks) theoretically require smaller sample sizes due to reduced outcome variance, they risk failing to capture the full treatment effect. Trial design must account for baseline wound characteristics, which should inform eligibility criteria and follow\u2010up.\n                  <\/jats:p>","DOI":"10.1111\/wrr.70189","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T05:01:19Z","timestamp":1784178079000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Longitudinal Healing and Amputation Trajectories in Diabetic Foot Ulcers: Predictive Power of Wound Area and Duration and Sample\u2010Size Implications From the Diabetic Foot Consortium"],"prefix":"10.1111","volume":"34","author":[{"given":"Charlotte","family":"Xu","sequence":"first","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian M.","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes University of Michigan Health  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Krambrink","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2305-4986","authenticated-orcid":false,"given":"Junyoung","family":"Park","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7881-7182","authenticated-orcid":false,"given":"Peter X. K.","family":"Song","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa L. Z.","family":"Jones","sequence":"additional","affiliation":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Crystal M.","family":"Holmes","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes University of Michigan Health  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kellen","family":"Chen","sequence":"additional","affiliation":[{"name":"University of Arizona College of Medicine  Tucson Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Ye","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giselle","family":"Kolenic","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sashwati","family":"Roy","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chandan K.","family":"Sen","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodica","family":"Pop\u2010Busui","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes University of Michigan Health  Ann Arbor Michigan USA"},{"name":"Division of Endocrinology, Diabetes and Clinical Nutrition Oregon Health &amp; Science University  Portland Oregon USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathie","family":"Spino","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4116-0268","authenticated-orcid":false,"given":"Irina","family":"Gaynanova","sequence":"additional","affiliation":[{"name":"School of Public Health, Department of Biostatistics University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmra1615439"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.jfas.2006.09.015"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.2147\/CWCMR.S64905"},{"key":"e_1_2_11_5_1","unstructured":"Center for Devices and Radiological Health The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)](2019) https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/510k\u2010program\u2010evaluating\u2010substantial\u2010equivalence\u2010premarket\u2010notifications\u2010510k."},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.70044"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/19322968221121152"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.5.692"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2003.06.006"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.13019"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.13237"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/21621918251405881"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1524\u2010475X.2001.00258.x"},{"issue":"3","key":"e_1_2_11_14_1","first-page":"141","article-title":"An Empirical Transition Matrix for Non\u2010Homogeneous Markov Chains Based on Censored Observations","volume":"5","author":"Aalen O. 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