IDEAL: InnovaMatrix® AC for Diabetic Foot Ulcers
This study is testing if adding InnovaMatrix® AC (a device made from porcine placental extracellular matrix) to standard care helps diabetic foot ulcers heal better than standard care alone. Researchers want to see if this combination leads to more complete ulcer closure within 12 weeks. You might be able to join if you are at least 21 years old, have type 1 or type 2 diabetes, and have a specific type of diabetic foot ulcer (Wagner Grade 1 or 2). The study aims to enroll 194 participants. The current recruitment status is unclear.
- Study design
- This is a multi-center, prospective, observer-blinded, randomized controlled clinical trial. It will compare two groups of participants, with about 194 people in total.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 12 weeks, focusing on ulcer closure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
At a glance
Conditions
Where it's being run
21 sites across 9 statesWho to contact
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What this trial measures
- 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