The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC127 and placebo (n = 25 evaluable subjects per group; n=75 total evaluable subjects) to identify the optimal dose of DSC127. Sustained tissue integrity will be evaluated for all subjects during a follow-up period at study weeks 16 and 24. Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups. Group 1: Placebo Vehicle Control Group 2: 0.03% DSC127 in Vehicle Group 3: 0.01% DSC127 in Vehicle The four week treatment period requires daily application of the treatment to the wound site. First application each week will be at the clinic and for the remainder of the week the patient self-administers the treatment. If wound healing occurs during the treatment or assessment periods a final assessment visit is conducted and the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States
Bay Area Footcare
Castro Valley, California, United States
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.
Time frame: Healing to occur within 12 weeks of first treatment
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Time frame: Duration of subject's participation (24 weeks)
The Rate of Re-epithelialization of the Ulcer Site.
The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
Time frame: 12 weeks
The Time to Re-epithelialization of the Ulcer Site.
Average time to complete re-epithelialization of baseline ulcer area.
Time frame: 24 weeks
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University of California, San Diego
San Diego, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Passavant Area Hospital
Jacksonville, Illinois, United States
Georgetown University Medical Center
Georgetown, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, United States
Warren General Hospital Wound Clinic
Warren, Pennsylvania, United States
...and 2 more locations