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

NCT06189638 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 280800-JSPL-PL-5-203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic Foot Infection; Diabetic Foot; Diabetic; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Clinical response

  the Investigator will grade the clinical response as （1）"infection resolved or cured" (all signs and symptoms of infection resolved);（2）"infection improving"(most, but not all, signs and symptoms of infection improved or resolved)（3）"treatment failure" (≥1 signs or symptoms of infection substantially worsening), (4)"unevaluable"(\<3 days of study treatment or patient lost to follow-up), or （5）"recurrence"(a previously cured or improved infection showing worsening of signs or symptoms of infection)

  At EOT (End-of-therapy: within 24 hours after the final dose)

Secondary Outcomes (5)

• Microbiological response

  Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.

• Comprehensive Response

  End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE):7-14 days after the final dose.

• Safety and tolerability

  Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose

• Clinical response

  Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.

• Wound infection Score and Total Wound Score

  At baseline, day 1, and at all other study visits, investigators will compile a "total wound score" that included ratings of signs and symptoms of infection, wound measurements (maximum length, width, and depth), and assessment of granulation tissue.

Study Arms (3)

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

EXPERIMENTAL

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

Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo

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

EXPERIMENTAL

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

Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo

Topical placebo (vehicle)

PLACEBO COMPARATOR

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).

Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo

Interventions

Antimicrobial Peptide PL-5 Topical Spray and Placebo 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.

Also known as: AMP PL-5 and Placebo

Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰); Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰); Topical placebo (vehicle)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 65 years.
• Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria.
• HbA1c ≤12% at screening.
• 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.
• 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.
• Female subjects must meet at least one of the following additional criteria:
• Surgically sterile with bilateral tubal ligation or hysterectomy.

You may not qualify if:

• 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).
• Foot deformities, calluses, corns, ingrown nails, fungal infections, which will impact infection or wound healing based on Investigator's judgement.
• Received any topical or systemic antimicrobial therapy within 7 days prior to study entry (Day 1).
• Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
• \> 1 infected foot ulcer.
• 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.
• 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.
• 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.
• Pregnant or lactating women.

Sponsors & Collaborators

• Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.: lead
• Parexel: collaborator

Study Sites (3)

ILD Research Center

Vista, California, 92081, United States

Location

Bioresearch Partner Holdings, LLLP

Miami, Florida, 33175, United States

Location

Santos Research Center, Corp

Tampa, Florida, 33615, United States

Location

Related Publications (2)

• Wei Y, Li Y, Li X, Zhao Y, Xu J, Wang H, Rong X, Xiong J, Chen X, Luo G, Lv G, Lin C, Han C, Yu H, Zhang Y, Tang S, Fan Y, Tu J, Xia C, Zu H, Liu W, Liu C, Liu J, Zhang B, Nong Q, Li T, Wang L, Song G, Su Y, Chen Z, Lai W, Fu Y, Yu J, Zhang P, Yang W, Yao G, Zhang H, Fan K, Dong H, Chen Y, Wu J; PL-5 Investigators. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415310. doi: 10.1001/jamanetworkopen.2024.15310.

  PMID: 38861260 BACKGROUND

• Wei Y, Wu J, Chen Y, Fan K, Yu X, Li X, Zhao Y, Li Y, Lv G, Song G, Rong X, Lin C, Wang H, Chen X, Zhang P, Han C, Zu H, Liu W, Zhang Y, Liu C, Su Y, Zhang B, Sun B, Wang L, Lai W, Liu J, Xia C, Ji G, Zhu F, Yu J, Ahemaiti A, Dong H, Chen M; PL-5 Investigators. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Ann Surg. 2023 Jan 1;277(1):43-49. doi: 10.1097/SLA.0000000000005508. Epub 2022 Jul 4.

  PMID: 35781462 BACKGROUND

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MeSH Terms

Conditions

Diabetic Foot; Wound Infection

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 3, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)