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

IF 5.9 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Pub Date : 2026-07-27 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

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引用次数: 0

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

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抗菌肽PL-5喷雾剂局部应用对轻度至中度糖尿病足溃疡感染的影响：一项多中心、随机、双盲、安慰剂对照临床试验

目的：评价外用抗菌肽PL-5 （Peceleganan）喷雾剂联合标准清创治疗轻度至中度感染糖尿病足溃疡（DFUs）的临床疗效和安全性。材料与方法：本多中心、随机、双盲、安慰剂对照试验在四所三级医院进行。符合条件的患者被随机分配到PL-5喷雾剂或安慰剂组，均接受标准化清创。主要终点是治疗结束后1天的临床缓解率（EOT1）。结果：各组间基线特征平衡。在EOT1时，PL-5组临床有效率显著高于安慰剂组（p < 0.05）。PL-5组不良事件发生率为24.24%，安慰剂组为33.33% (p < 0.05)，无严重药物相关不良事件发生。PL-5的临床有效率显著提高，但总体微生物根除组间差异无统计学意义。然而，在耐药菌患者亚群中，PL-5的清除率明显更高，这表明它具有治疗耐药感染的潜力。结论：外用PL-5喷雾剂改善了轻中度感染糖尿病足溃疡的临床结果，并在耐药感染亚组中取得了更好的病原体清除效果。它代表了一种有希望的低耐药性局部选择，用于管理轻度至中度DFU感染。试验注册：中文临床试验注册号：ChiCTR2300068632。

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来源期刊

Journal of Diabetes ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

2.20%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.