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

NCT06189638 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-25

No results posted yet for this study

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

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

Antimicrobial Peptide PL-5 Topical Spray and Placebo

Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2027-04-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189638 on ClinicalTrials.gov