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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2027-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Antimicrobial Peptide PL-5 Topical Spray and placebo will not be identical in physical appearance. In order to ensure the objectivity of evaluation, the Sponsor, investigators, and other persons involved in the subject evaluation and trial implement (e.g., the Sponsor, subjects, investigators, clinical research associates, data managers, statistician, etc.) should be blinded. Blinded persons including investigators should not try to identify the group of subjects. Blind codes encrypted electronically will be stored in the Sponsor's department of medicine supply during clinical trials, and unblinding is not allowed before database lock.

Study Groups

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Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰)

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 Type EXPERIMENTAL

Antimicrobial Peptide PL-5 Topical Spray and Placebo

Intervention Type DRUG

Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.

Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰)

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 Type EXPERIMENTAL

Antimicrobial Peptide PL-5 Topical Spray and Placebo

Intervention Type DRUG

Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.

Topical placebo (vehicle)

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).

Group Type PLACEBO_COMPARATOR

Antimicrobial Peptide PL-5 Topical Spray and Placebo

Intervention Type DRUG

Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.

Interventions

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Antimicrobial Peptide PL-5 Topical Spray and Placebo

Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.

Intervention Type DRUG

Other Intervention Names

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AMP PL-5 and Placebo

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 to 65 years.
2. Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria.
3. HbA1c ≤12% at screening.
4. At baseline visit (after any required debridement), presence of Grade 2 diabetic foot infection \[Grade 2 of the International Working Group on the Diabetic Foot (IWGDF) classification\]

Infection present, as defined by the presence of at least 2 of the following items:
* Local swelling or induration
* Erythema \>0.5 cm to ≤2 cm around the ulcer.
* Local tenderness or pain
* Local increased warmth
* Purulent discharge (thick, opaque to white, or sanguineous secretion)

Mild infection of an ulcer is defined as:

Presence of ≥2 manifestations of inflammation (purulence or erythema, tenderness, warmth, or induration), but any cellulitis/erythema extends ≤2cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness.
5. Voluntary written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
6. Female subjects must meet at least one of the following additional criteria:

* Surgically sterile with bilateral tubal ligation or hysterectomy.
* Postmenopausal for at least one year.
* If of childbearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence

Exclusion Criteria

1. Another cause of the inflammatory response of the skin around the ulcer (such as a trauma, gout, acute Charcot neuro-arthropathy, fracture, thrombosis, or venous stasis).
2. Foot deformities, calluses, corns, ingrown nails, fungal infections, which will impact infection or wound healing based on Investigator's judgement.
3. Received any topical or systemic antimicrobial therapy within 7 days prior to study entry (Day 1).
4. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
5. \> 1 infected foot ulcer.
6. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
7. Bone or joint involvement is suspected based on clinical examination or plain X-ray.
8. Arterial brachial index (ABI) \<0.5 or ankle pressure \<50 mmHg. If ABI is \>1.3 (medial calcification is present), then only subjects meeting secondary testing requirements including either a toe pressure ≥30 mmHg, a transcutaneous pressure of oxygen ≥50 mmHg, or a skin perfusion pressure ≥40 mmHg are allowed. For subjects with ABI \>1.3, only the initial secondary test after ABI should be used for this assessment. A documented ABI within 3 months prior to Screening is acceptable, as is the initially performed secondary testing method for subjects with ABI \>1.3.
9. The subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period or cannot safely monitor the infection status at home.
10. Pregnant or lactating women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No