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
Status	Clinical Trial	Phase
Completed	`NCT02652754` - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers	Phase 1
Completed	`NCT01070433` - A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers	Phase 2
Completed	`NCT00971048` - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds	N/A
Terminated	`NCT00762138` - The AutoloGel™ Post-Market Surveillance (TAPS) Program	N/A
Completed	`NCT00578604` - Non-Invasive Assessment of Wound Healing With Optical Methods	N/A
Completed	`NCT05417425` - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers	Phase 1
Completed	`NCT02631512` - Evaluation of Woulgan in Diabetic Foot Ulcer	Phase 4
Terminated	`NCT01816633` - Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers	N/A
Completed	`NCT02222376` - Effect of Topic Pirfenidone in Diabetic Ulcers	Phase 3
Completed	`NCT01454401` - LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers	N/A
Completed	`NCT01221207` - Instant Total Contact Cast to Heal Diabetic Foot Ulcers	N/A
Withdrawn	`NCT01105884` - Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers	N/A
Completed	`NCT01291160` - Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers	Phase 2/Phase 3
Completed	`NCT00536744` - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers	Phase 3
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
Terminated	`NCT02667327` - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer	Phase 3
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

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