Status:
ACTIVE_NOT_RECRUITING
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
Lead Sponsor:
Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
Collaborating Sponsors:
Parexel
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 infe...
Detailed Description
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 infe...
Eligibility Criteria
Inclusion
- 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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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.
- 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
- 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.
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06189638
Start Date
January 30 2024
End Date
December 30 2027
Last Update
May 25 2025
Active Locations (3)
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1
ILD Research Center
Vista, California, United States, 92081
2
Bioresearch Partner Holdings, LLLP
Miami, Florida, United States, 33175
3
Santos Research Center, Corp
Tampa, Florida, United States, 33615