{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T14:41:20Z","timestamp":1792593680074,"version":"4.5.0"},"reference-count":11,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T00:00:00Z","timestamp":1712102400000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad\u2010spectrum topical anti\u2010infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double\u2010blind, placebo\u2010controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well\u2010tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5\u2009ng\/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3\u2010fold decrease in ulcer size compared to the placebo group (85% vs. 30%, <jats:italic>p<\/jats:italic>\u2009=\u20090.27). Furthermore, the incidence of ulcer\u2010related lower limb amputations was approximately 6\u2010fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (<jats:italic>p<\/jats:italic>\u2009=\u20090.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).<\/jats:p>","DOI":"10.1111\/iwj.14817","type":"journal-article","created":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T07:04:39Z","timestamp":1712127879000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"21","author":[{"given":"Benjamin A.","family":"Lipsky","sequence":"first","affiliation":[{"name":"Department of Medicine University of Washington  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul J.","family":"Kim","sequence":"additional","affiliation":[{"name":"Departments of Plastic Surgery and Orthopaedic Surgery University of Texas Southwestern  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Murphy","sequence":"additional","affiliation":[{"name":"Medpace, Inc  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia A.","family":"McKernan","sequence":"additional","affiliation":[{"name":"Microbion Corporation  Bozeman Montana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Department of Surgery School of Medicine at the University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brett H. 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