Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double-blind, placebo-controlled trial.

Autor: Lipsky BA; Department of Medicine, University of Washington, Seattle, Washington, USA., Kim PJ; Departments of Plastic Surgery and Orthopaedic Surgery, University of Texas Southwestern, Dallas, Texas, USA., Murphy B; Medpace, Inc, Cincinnati, Ohio, USA., McKernan PA; Microbion Corporation, Bozeman, Montana, USA., Armstrong DG; Department of Surgery, School of Medicine at the University of Southern California, Los Angeles, California, USA., Baker BHJ; Microbion Corporation, Bozeman, Montana, USA.
Jazyk: angličtina
Zdroj: International wound journal [Int Wound J] 2024 Apr; Vol. 21 (4), pp. e14817.
DOI: 10.1111/iwj.14817
Abstrakt: This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, 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-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/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-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). 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).
(© 2024 Microbion Corporation. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)
Databáze: MEDLINE
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