Effect of Topical Application of Antimicrobial Peptide PL-5 (Peceleganan) Spray on Mild to Moderate Infection of Diabetic Foot Ulcers: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Abstract
Aims: To evaluate the clinical efficacy and safety of topical antimicrobial peptide PL-5 (Peceleganan) spray combined with standard debridement in the treatment of mildly to moderately infected diabetic foot ulcers (DFUs).
Materials and methods: This multicenter, randomized, double-blind, placebo-controlled trial was conducted in four tertiary hospitals. Eligible patients were randomized to PL-5 spray or placebo, both receiving standardized debridement. The primary endpoint was clinical response rate at 1 day after end of treatment (EOT1).
Results: Baseline characteristics were balanced between groups. The clinical response rate at EOT1 was significantly higher in the PL-5 group than in the placebo group (p 0.05). Adverse event rates were 24.24% in the PL-5 group and 33.33% in the placebo group (p > 0.05), with no serious drug-related adverse events. PL-5 showed a significant improvement in clinical effective rate, but overall microbiological eradication was not significantly different between groups. However, in the subset of patients with drug-resistant bacteria, PL-5 demonstrated a significantly higher clearance rate, suggesting potential for treatment of resistant infections.
Conclusions: Topical PL-5 spray improves clinical outcomes in mild-to-moderate infected diabetic foot ulcers and achieves superior pathogen clearance among drug-resistant infection subgroups. It represents a promising low-resistance topical option for managing mild to moderate DFU infections.
Trial…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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