Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic… (NCT06189638) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
United States90 participantsStarted 2024-01-30
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 \[Grade 2 of the International Working Group on the Diabetic Foot (IWGDF) classification\]
✓. 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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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:
Exclusion criteria
✕. 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.
What they're measuring
1
Clinical response
Timeframe: At EOT (End-of-therapy: within 24 hours after the final dose)
✕. 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.