Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard o… (NCT06674980) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
United States177 participantsStarted 2024-12-20
Plain-language summary
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age or older.
✓. Must have diagnosis of type 1 or 2 Diabetes mellitus.
✓. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
✓. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
✓. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
✓. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
✓. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
✓. ABI between 0.7 and \<= 1.3
Exclusion criteria
✕. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.
✕0. Subject must consent to using the prescribed offloading method for the duration of the study.
✕1. Subject must agree to attend weekly study visits.
What they're measuring
1
Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.