Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double‐blind, placebo‐controlled trial
Clinical Summary
View sourceWhat was studied
A Phase 1b randomized, double-blind, placebo-controlled, multicenter trial tested topical pravibismane as adjunctive therapy for moderate or severe infected chronic diabetic foot ulcers, comparing pravibismane (n=39) versus placebo (n=13) for safety (tolerability, pharmacokinetics) and exploratory efficacy (ulcer size change, amputations).
Key findings
Pravibismane had minimal systemic absorption (blood levels below 0.5 ng/mL or in the low nanomolar range) and no treatment-emergent or serious adverse events attributed to the drug; ulcer size decreased 85% vs 30% (p=0.27) and ulcer-related lower-limb amputations were 2.6% vs 15.4% (p=0.15) for pravibismane vs placebo.
Study limitations
Very small sample (39 vs 13) with non-significant efficacy comparisons; early-phase (Phase 1b) design limits inference on effectiveness.
Clinical implications
Topical pravibismane appears well tolerated with negligible systemic exposure in infected DFUs, but efficacy signals (ulcer size reduction and fewer amputations) were not statistically significant. Consider it promising yet investigational pending confirmation in larger, adequately powered trials.
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