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.
Subjects at least 21 years old. At least 50% of the enrolled population must be > 65 years of age.
Known history of type 1 or type 2 diabetes.
Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic.
BMI ≤45
None
Parallel
InnovaMatrix® AC
DeviceSOC plus weekly application of the study device
To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 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
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