A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With P… (NCT06618612) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
United States170 participantsStarted 2024-08-19
Plain-language summary
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age or older.
✓. Diagnosis of type 1 or 2 Diabetes mellitus.
✓. At enrollment, target ulcer with a minimum surface area of 1.0 cm2
✓. The target ulcer must have been present for a minimum of 4 weeks
✓. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
✓. The target ulcer must be Wagner 1 or 2 grade
✓. The affected limb must have adequate perfusion confirmed by vascular assessment.
Exclusion criteria
✕. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
✕0. The potential subject must consent to using the prescribed offloading method for the duration of the study.
✕1. The potential subject must agree to attend the weekly study visits required by the protocol.
✕2. The potential subject must be willing and able to participate in the informed consent process.
✕. The potential subject is known to have a life expectancy of \< 6 months.
✕. The potential subject's target ulcer is not secondary to diabetes.
What they're measuring
1
Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure