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.

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). The clearance rate of drug-resistant bacteria at EOT1 was 71.43% in the PL-5 group versus 50% in the control group (p < 0.05). No significant differences were observed in overall microbiological eradication rates at EOT1 (57.89% vs. 33.33%) or EOT7 (64.71% vs. 40.00%) (both 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 REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2300068632.