{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T12:06:34Z","timestamp":1791893194861,"version":"4.3.4"},"reference-count":27,"publisher":"Mark Allen Group","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Wound Care"],"published-print":{"date-parts":[[2026,10,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>PREPARE was a prospective, multicentre, randomised controlled trial evaluating purified native type 1 collagen extracellular matrix plus polyhexamethylene biguanide (PCMP) with standard of care (SoC) versus SoC alone in patients with hard-to-heal diabetic foot ulcers (DFUs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method:<\/jats:title>\n                    <jats:p>\n                      Across 25 US sites, patients with type 1 or type 2 diabetes and hard-to-heal DFUs measuring 1\u201325cm\n                      <jats:sup>2<\/jats:sup>\n                      were enrolled. Patients demonstrating \u226540 percent area reduction (PAR) during four weeks of screening were excluded to restrict the study population to those with hard-to-heal wounds. SoC included sharp debridement, saline cleansing, use of moisture-balancing dressings and offloading. The primary endpoint was complete wound closure within 12 weeks, confirmed two weeks later. Secondary endpoints included time to closure, PAR and adverse events (AEs).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 170 patients were randomised (PCMP+SoC, n=96; SoC alone, n=74). Complete wound closure occurred in 42% of patients receiving PCMP+SoC versus 27% of patients receiving SoC alone (absolute difference 14.6%; 95% confidence interval: 0.15%, 27.9%; p=0.047). Mean PAR was greater with PCMP+SoC than with SoC alone (75.23% versus 58.06%, respectively). No AEs or serious AEs were attributed to PCMP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this study, use of PCMP+SoC significantly improved 12-week closure outcomes in patients with hard-to-heal DFUs compared with SoC alone, supporting its use as an adjunctive antimicrobial barrier for these types of wounds.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.12968\/jowc.2026.0369","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T14:23:00Z","timestamp":1790950980000},"page":"876-886","source":"Crossref","is-referenced-by-count":0,"title":["Native collagen matrix plus PHMB antimicrobial in hard-to-heal diabetic foot ulcers: results from the PREPARE randomised controlled trial"],"prefix":"10.12968","volume":"35","author":[{"given":"Leandro Tapia","family":"Garcia","sequence":"first","affiliation":[{"name":"SerenaGroup, Inc, Norwell, MA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaminelli","family":"Banks","sequence":"additional","affiliation":[{"name":"Advanced Foot Care, Phoenix, AZ, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Advanced Podiatry Research Group, South Miami, FL, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn M","family":"Cazzell","sequence":"additional","affiliation":[{"name":"Limb Preservation Platform, Inc., Fresno, CA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph M","family":"Caporusso","sequence":"additional","affiliation":[{"name":"Futuro Clinical Trials, McAllen, TX, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Windy","family":"Cole","sequence":"additional","affiliation":[{"name":"Kent State University College of Podiatric Medicine, Independence, OH, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dereck","family":"Shi","sequence":"additional","affiliation":[{"name":"SerenaGroup, Inc, Norwell, MA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Cook","sequence":"additional","affiliation":[{"name":"SerenaGroup, Inc, Norwell, MA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brianna","family":"Tramelli","sequence":"additional","affiliation":[{"name":"SerenaGroup, Inc, Norwell, MA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas E","family":"Serena","sequence":"additional","affiliation":[{"name":"SerenaGroup, Inc, Norwell, MA, US"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"5130","reference":[{"key":"e_1_3_2_1_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)01655-5"},{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1615439"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.10578"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/07853890.2016.1231932"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-020-00383-2"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0182081"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2176"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.3657"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.6.1879"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2024.0141"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD011255.pub2"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.3644"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/GOX.0000000000002047"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.2217\/cer-2020-0058"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.25270\/wnds\/20174"},{"key":"e_1_3_2_16_2","unstructured":"PuraPly Antimicrobial [package insert]. 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