Antimicrobial Peptide Spray for Diabetic Foot

(PL-5 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new antimicrobial peptide spray, Antimicrobial Peptide PL-5 Topical Spray, to determine its effectiveness in healing mild infections in diabetic foot ulcers. Researchers aim to assess whether the spray can reduce infection and improve safety compared to a placebo. The trial includes three groups: two different strengths of the peptide spray and a placebo group. This study may suit individuals with diabetes who have a mild infection in their foot ulcer and have not recently used antibiotic treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the Antimicrobial Peptide PL-5 Topical Spray is generally safe. Previous studies reported no serious side effects. Testing on wounds found the spray to be safe and effective. Although researchers continue to study this treatment, these results suggest it is well-tolerated. For those considering joining a clinical trial for this treatment, the current safety data is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for diabetic foot ulcers, which often include antibiotics and dressings, the Antimicrobial Peptide PL-5 Topical Spray offers a novel approach by utilizing antimicrobial peptides to combat infection. These peptides are known for their ability to directly disrupt bacterial membranes, potentially offering a targeted and efficient method to reduce bacterial load. Moreover, the spray format allows for easy application, potentially enhancing patient compliance and comfort. Researchers are excited about this treatment because it could provide a faster, more effective way to heal diabetic foot ulcers, reducing the risk of complications and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for diabetic foot ulcers?

Research has shown that Antimicrobial Peptide PL-5 Topical Spray effectively treats mild infections in diabetic foot ulcers. One study found that PL-5 spray helped heal these infections, offering promise for individuals with diabetic foot conditions. In this trial, participants will receive either the Antimicrobial Peptide PL-5 Topical Spray at different concentrations or a placebo. Similar treatments have also demonstrated effectiveness in healing diabetic foot ulcers by reducing infection. The treatment is considered safe and effective for skin wound infections, suggesting it may work well for diabetic foot ulcers too. Overall, early findings indicate that PL-5 could be a helpful option for managing these infections. ^{1 3 4 6 7}

Who Is on the Research Team?

Mingxia Chen, MD, MS

Principal Investigator

Jiangsu Protelight Pharmaceutical & Biotechnology Co., Ltd

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/173-OR/155207/173-OR-A-Clinical-Study-of-Novel-Antimicrobial

173-OR: A Clinical Study of Novel Antimicrobial Peptide PL-5 ... We studied the clinical efficacy and safety of investigational PL-5 spray in the treatment of mild to moderate diabetic foot ulcers in combined ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06189638

NCT06189638 | Phase II Study to Evaluate Efficacy and ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481886/

Topical antimicrobial agents for treating foot ulcers in people ... A recent Cochrane review summarised and analysed the data on the effectiveness of systemic antibiotic therapy for diabetic foot infections (Selva Olid 2015).

4. withpower.com withpower.com/trial/phase-2-diabetic-foot-2024-30fe4

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

5. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2023/01000/efficacy_and_safety_of_pl_5__peceleganan__spray.9.aspx

Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound... Conclusions: Antimicrobial peptide PL-5 spray is safe and effective for the treatment of skin wound infections. Trial Registration: ChiCTR2000033334.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9762708/

Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound ... No severe adverse event related to the application of PL-5 was reported. Conclusions: Antimicrobial peptide PL-5 spray is safe and effective for the treatment ...

7. ctv.veeva.com ctv.veeva.com/study/phase-ii-study-to-evaluate-efficacy-and-safety-of-amp-peptide-pl-5-in-mild-infections-of-diabetic-fo

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