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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
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.
ILD Research Center
Vista, California, United States
Bioresearch Partner Holdings, LLLP
Miami, Florida, United States
Santos Research Center, Corp
Tampa, Florida, United States
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)
Time frame: At EOT (End-of-therapy: within 24 hours after the final dose)
Microbiological response
Microbiological culture examination of wound tissue; Analysis of drug sensitivity test results; Analysis of MIC50, MIC90, geometric mean inhibitory concentration and range results of clinically isolated pathogenic bacteria. At baseline, day 1, and at all other study visits, Investigators will culture samples obtained from the wound at which culturable material and signs of infection are present. They will obtain specimens using tissue curettage with a sterile scalpel, place them into transport media, and ship them to the designated central laboratory for species identification and antibiotic susceptibility testing. For specific operations of bacteriological examination of wound tissue, please refer to the clinical microbiology operation manual. Result: 1)Resolved;2) Improved;3)Failure 4) Colonization 5) Superinfection.
Time frame: 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
At EOT and PTE, the Investigator will grade the comprehensive response as (1)"cure"(patients are clinically cured, and the bacteria are eradicated or presumed eradicated.);(2)"failure" (patients are classified as clinical failure or/and microbiological responses are failure and superinfection) or (3)"indeterminate"(if both clinical and microbiological responses are indeterminate).
Time frame: 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
The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), and clinically significant changes in physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG)
Time frame: 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
At each visit after enrollment, 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)
Time frame: 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
A "wound infection score" was semiquantitatively assessed by grading each of 7 parameters with a score of 0-3: (1) purulent drainage, (2) nonpurulent drainage, (3) erythema, (4) induration, (5) tenderness, (6) pain, and (7) local warmth.
Time frame: 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.
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