Antimicrobial Peptide Spray for Diabetic Foot
(PL-5 Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Mingxia Chen, MD, MS

Principal Investigator

Jiangsu Protelight Pharmaceutical &amp; Biotechnology Co., Ltd

Eligibility Criteria

This trial is for non-hospitalized individuals aged 18-65 with mild diabetic foot ulcer infections. Participants must have controlled diabetes (Type I or II) with HbA1c ≤12%, and show specific signs of infection without severe complications. Women must use birth control if applicable, and all participants should be able to attend regular study visits.

Inclusion Criteria

I am between 18 and 65 years old.

I have Type 1 or Type 2 diabetes and am not currently hospitalized.

I have a mild infection in my ulcer, with signs of inflammation but no severe complications.

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Exclusion Criteria

Foot deformities, calluses, corns, ingrown nails, fungal infections, which will impact infection or wound healing based on Investigator's judgement

My skin inflammation around the ulcer is not due to other causes like injury or gout.

I have an infected foot ulcer due to diabetes, complicated by issues like exposed surgical materials.

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Treatment Details

Interventions

Antimicrobial Peptide PL-5 Topical Spray (Antimicrobial Peptide)

Trial OverviewThe trial tests a new Antimicrobial Peptide PL-5 Topical Spray against a placebo in treating mild infections of diabetic foot ulcers over a 14-day period. Patients are randomly assigned to one of two different strengths of the spray or a placebo, without knowing which they receive.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰)Experimental Treatment1 Intervention

Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (2‰)

Group II: Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰)Experimental Treatment1 Intervention

Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰)

Group III: Topical placebo (vehicle)Placebo Group1 Intervention

Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle).