Antimicrobial Peptide Spray for Diabetic Foot

(PL-5 Trial)

Recruiting at 19 trial locations

Overseen By Jing Gao

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Antimicrobials

Disqualifiers: Foot deformities, Bone involvement, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not used any topical or systemic antimicrobial therapy (medications to treat infections) within 7 days before starting the study. If you are currently on such medications, you may need to stop them before participating.

What data supports the effectiveness of the antimicrobial peptide PL-5 topical spray treatment for diabetic foot?

Research shows that antimicrobial peptides, like PL-5, can help heal diabetic wounds by fighting bacteria and supporting skin repair. A study on PL-5 spray found it effective for treating wound infections, and similar peptides have shown promise in healing diabetic foot ulcers by reducing bacterial biofilms and promoting tissue growth. ^{1 2 3 4 5}

Is the Antimicrobial Peptide PL-5 Topical Spray safe for use in humans?

The Antimicrobial Peptide PL-5 (Peceleganan) Spray has been evaluated for safety in treating wound infections, and a study found it to be safe for use. Additionally, a similar peptide, PLG0206, was tested intravenously in healthy subjects and was found to be safe and well-tolerated, with most side effects being mild. ^{2 4 6 7 8}

How is the drug Antimicrobial Peptide PL-5 Topical Spray different from other treatments for diabetic foot?

The Antimicrobial Peptide PL-5 Topical Spray is unique because it uses antimicrobial peptides, which are small proteins that can kill bacteria and help heal wounds, directly on the skin. This approach targets the infection at the site of the wound, potentially reducing the need for systemic antibiotics that can have more side effects. ^{1 2 3 4 9}

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 & 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 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.

I am a woman who is either not able to have children, in menopause, or using reliable birth control.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray or placebo

2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1-2 visits (in-person)

Treatment Details

Interventions

• Antimicrobial Peptide PL-5 Topical Spray

Trial Overview The 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

Group I: Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰) Experimental Treatment 1 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 Treatment 1 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 Group 1 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).

Who Is Running the Clinical Trial?

Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.

Lead Sponsor

Trials

1

Recruited

90+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Wound-Healing Peptides for Treatment of Chronic Diabetic Foot Ulcers and Other Infected Skin Injuries. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Human Cathelicidin Antimicrobial Peptide LL-37 as a Potential Treatment for Polymicrobial Infected Wounds. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Antimicrobial Peptides for Diabetic Wound Healing: Preclinical and Clinical Studies. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of a First-in-Human Engineered Cationic Peptide, PLG0206, Intravenously Administered in Healthy Subjects. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Nanoparticles Encapsulated with LL37 and Serpin A1 Promotes Wound Healing and Synergistically Enhances Antibacterial Activity. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Challenges of Antimicrobial Peptides for Therapeutic Applications. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pexiganan in Combination with Nisin to Control Polymicrobial Diabetic Foot Infections. [2020]