Overview

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

Status:
Not yet recruiting

Trial end date:
2025-06-30

Target enrollment:

Participant gender:

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

Phase:

Phase 2

Details

Lead Sponsor:

Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.

Collaborator:

Parexel

Treatments:

Anti-Bacterial Agents
Anti-Infective Agents