Journal of Diabetes · Published 2026-07-01 · DOI 10.1111/1753-0407.70255
Li Qian, Xinjuan Sun, Rourou Chen, Qiuyu Lin, Chen Yu, Guofeng Wang, Wen Hu, Jianfang Che, Aiping Wang, Yuxin Chen, Yu Liu
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). 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
Abstract from DOAJ. Public domain (CC0 1.0).
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Qian, L., Sun, X., Chen, R., et al. (2026). 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. Journal of Diabetes. https://doi.org/10.1111/1753-0407.70255