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Antimicrobial Peptide

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

Phase 2

Waitlist Available

Research Sponsored by Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 to 65 years

Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria

Must not have

Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer

Bone or joint involvement is suspected based on clinical examination or plain X-ray

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of therapy (eot): within 24 hours after the final dose. post-therapy evaluation (pte):7-14 days after the final dose.

Summary

This trial is testing the effectiveness and safety of a topical spray called Antimicrobial Peptide PL-5 in treating mild infections of diabetic foot ulcers. Participants will be randomly assigned to receive either the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include skin irritation at the application site, allergic reactions to ingredients in the spray, or no improvement in infection leading to worsening symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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

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My diabetic foot infection is classified as moderate.

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I have an infection with symptoms like swelling, redness, pain, warmth, or pus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need ongoing antibiotics for an infection, including a diabetic foot ulcer.

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My doctor suspects bone or joint issues based on an exam or X-ray.

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

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I have more than one infected foot ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of therapy (eot): within 24 hours after the final dose. post-therapy evaluation (pte):7-14 days after the final dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of therapy (eot): within 24 hours after the final dose. post-therapy evaluation (pte):7-14 days after the final dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of therapy (eot): within 24 hours after the final dose. post-therapy evaluation (pte):7-14 days after the final dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Clinical response

Comprehensive Response

Microbiological response

+2 more

Trial Design

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).

0 / 8Eligibility criteria met