Phase II Study to Evaluate Efficacy & Safety of AMP Peptide PL-5 in Mild

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

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. Approximately 90 patients (30 per treatment group) will be randomized in this study. 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 placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle). 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. The duration of the whole study is planned for 24 months; the duration of each participant is about 4-5 weeks, including Screening period/Baseline (about 7 days), treatment period (about 14 days), Follow-up period (about 7-14 days). No interim analysis will be performed in this study. This study is a phase II study, and no statistical hypothesis is proposed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06189638
Study type	Interventional
Source	Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
Contact	Ming M Liu, MD, MS
Phone	+86-15692176002
Email	liu.ming@protelight.com
Status	Not yet recruiting
Phase	Phase 2
Start date	January 8, 2024
Completion date	June 30, 2025

View Details

See also
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Terminated	`NCT00316537` - Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers	Phase 1/Phase 2
Completed	`NCT00013299` - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3	Phase 2
Completed	`NCT00013286` - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk	Phase 2
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Not yet recruiting	`NCT00916292` - Safety Study of Topical Human FGF-1 for Wound Healing	Phase 1
Completed	`NCT01154374` - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)	Phase 2
Not yet recruiting	`NCT02672280` - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms