Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers

Summary

This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and topical placebo (vehicle) spray. In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study

Timeline

Start

2024-01-30

Primary completion

2027-04-30

Completion

2027-12-30

Publications

• Background Wei Y, Li Y, Li X, Zhao Y, Xu J, Wang H, Rong X, Xiong J, Chen X, Luo G, Lv G, Lin C, Han C, Yu H, Zhang Y, Tang S, Fan Y, Tu J, Xia C, Zu H, Liu W, Liu C, Liu J, Zhang B, Nong Q, Li T, Wang L, Song G, Su Y, Chen Z, Lai W, Fu Y, Yu J, Zhang P, Yang W, Yao G, Zhang H, Fan K, Dong H, Chen Y, Wu J; PL-5 Investigators. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415310. doi: 10.1001/jamanetworkopen.2024.15310.
• Background Wei Y, Wu J, Chen Y, Fan K, Yu X, Li X, Zhao Y, Li Y, Lv G, Song G, Rong X, Lin C, Wang H, Chen X, Zhang P, Han C, Zu H, Liu W, Zhang Y, Liu C, Su Y, Zhang B, Sun B, Wang L, Lai W, Liu J, Xia C, Ji G, Zhu F, Yu J, Ahemaiti A, Dong H, Chen M; PL-5 Investigators. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Ann Surg. 2023 Jan 1;277(1):43-49. doi: 10.1097/SLA.0000000000005508. Epub 2022 Jul 4.

Drugs

Indications