A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers
Overview
- Phase
- Phase 2
- Intervention
- Antimicrobial Peptide PL-5 Topical Spray and Placebo
- Conditions
- Diabetic Foot Ulcers
- Sponsor
- Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Clinical response
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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
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 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.
Investigators
Eligibility Criteria
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 \[Grade 2 of the International Working Group on the Diabetic Foot (IWGDF) classification\]
- •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)
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.
- •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.
- •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.
Arms & Interventions
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‰)
Intervention: Antimicrobial Peptide PL-5 Topical Spray and Placebo
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‰)
Intervention: Antimicrobial Peptide PL-5 Topical Spray and Placebo
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).
Intervention: Antimicrobial Peptide PL-5 Topical Spray and Placebo
Outcomes
Primary Outcomes
Clinical response
Time Frame: At EOT (End-of-therapy: within 24 hours after the final dose)
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)
Secondary Outcomes
- 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)
- Comprehensive Response(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.)
- 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.)
- 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.)