IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Not Applicable
Not yet recruiting
- Conditions
- Wound HealUlcer
- Interventions
- Device: InnovaMatrix® AC
- 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
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 194
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care + Intervention InnovaMatrix® AC SOC arm with the following modifications: * Consecutive weekly application of PPECM for the 12-week study period. * Subjects will receive no more than 12 applications of PPECM Note: PPECM should be applied after standard wound cleansing and debridement procedures, prior to the application of primary wound dressing, in accordance with the IFU.
- 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 (3)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
US-FAS
🇺🇸Raleigh, North Carolina, United States
Northwell Health Comprehensive Wound Healing Center
🇺🇸New Hyde Park, New York, United States