Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety
Summary:** In a phase 1b multi-center RCT, topical pravibismane—a broad-spectrum anti-infective targeting biofilm pathogens—was safe and well-tolerated in 53 patients with moderate-severe diabetic foot ulcer infections over 4 weeks as adjunct to standard care. It achieved ~3x greater ulcer size reduction, substantially lower amputation rates, and microbiological clearance of key bacteria vs placebo. The findings warrant further development for resistant infections in DFUs, where biofilms hinder 50% of cases.
Key Highlights:
- Trial: Double-blind, placebo-controlled; 53 participants; primary: safety; secondary: size reduction, amputations, microbiology.
- Safety: Well-tolerated across doses; no significant issues.
- Efficacy: 3x ulcer reduction; lower amputations; effective vs biofilm-forming pathogens.
- Authors: Benjamin Lipsky, David Armstrong, Kim PJ, Murphy B, McKernan PA, Baker BHJ.
- Implications: Addresses AMR; potential for faster closure in infected DFUs.
Keywords: topical pravibismane, diabetic foot infection, biofilm, amputation rates, phase 1b trial