IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
- Conditions
- Wound HealUlcer
- Registration Number
- NCT06616844
- Lead Sponsor
- ConvaTec Inc.
- Brief Summary
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 194
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 12 weeks. 12 weeks Measure the incidence of complete wound closure, defined as 100% reepithelialization of the wound without drainage, confirmed at a second clinical visit occurring at least 2-weeks after the visit where wound closure was initially observed
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Center for Clinical Research
🇺🇸San Francisco, California, United States
ILD Research Center
🇺🇸Vista, California, United States
Dinamo Research and Diagnostic Center
🇺🇸Hialeah, Florida, United States
Angel City Research
🇺🇸Los Angeles, California, United States
Indiana Foot & Ankle
🇺🇸Jasper, Indiana, United States
US-FAS
🇺🇸Raleigh, North Carolina, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Northwell Health Comprehensive Wound Healing Center
🇺🇸New Hyde Park, New York, United States
Center for Clinical Research🇺🇸San Francisco, California, United StatesGayana SarkisovaContact800-363-1069gayana@ccr-trials.comAlexander ReyzelmanPrincipal Investigator