{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T21:43:03Z","timestamp":1791495783850,"version":"4.3.4"},"reference-count":51,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2024,3,5]],"date-time":"2024-03-05T00:00:00Z","timestamp":1709596800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Advances in Wound Care"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach:<\/jats:title>\n                    <jats:p>We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (\u221226%), reduced recurrence (\u221291%), and reduced AOs (\u221271%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (\u221223%), reduced recurrence (\u221280%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69\u20131.14).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare's most frequent wounds.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/wound.2023.0143","type":"journal-article","created":{"date-parts":[[2024,3,5]],"date-time":"2024-03-05T09:10:41Z","timestamp":1709629841000},"page":"350-362","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence"],"prefix":"10.1177","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1161-6954","authenticated-orcid":false,"given":"William V.","family":"Padula","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical &amp; Health Economics, Alfred E. Mann School of Pharmacy &amp; Pharmaceutical Sciences, University of Southern California, Los Angeles, California, USA."},{"name":"The Leonard D. Schaeffer Center for Health Policy &amp; Economics, University of Southern California, Los Angeles, California, USA."},{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8620-6584","authenticated-orcid":false,"given":"Swetha","family":"Ramanathan","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin G.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald","family":"Rogan","sequence":"additional","affiliation":[{"name":"Rogan Consulting, Sacramento, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Armstrong","sequence":"additional","affiliation":[{"name":"The Leonard D. Schaeffer Center for Health Policy &amp; Economics, University of Southern California, Los Angeles, California, USA."},{"name":"Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,3,5]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2023.2232256"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.07.007"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12902-018-0327-2"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-020-00383-2"},{"issue":"5","key":"e_1_3_6_6_2","first-page":"892","article-title":"The impact of foot ulceration and amputation on mortality in diabetic patients","volume":"13","author":"Jupiter DC","year":"2016","unstructured":"Jupiter DC, , Thorud JC, , Buckley CJ, et al. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. Int Wound J, 2016; 13(5):892\u2013903.","journal-title":"I: From ulceration to death, a systematic review. Int Wound J"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamasurg.2020.3845"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.10578"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.48152"},{"issue":"7","key":"e_1_3_6_10_2","first-page":"1","article-title":"Skin substitutes for adults with diabetic foot ulcers and venous leg ulcers: A health technology assessment","volume":"21","author":"Ontario Health (Quality)","year":"2021","unstructured":"Ontario Health (Quality). Skin substitutes for adults with diabetic foot ulcers and venous leg ulcers: A health technology assessment. 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