A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous… (NCT06453187) | Clinical Trial Compass
By InvitationNot Applicable
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
United States350 participantsStarted 2024-11-18
Plain-language summary
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects must be at least 21 years of age or older.
✓. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
✓. At Screening Visit 1 and at Randomization, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
✓. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
✓. 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, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the malleolus.
✓. The 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 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.
What they're measuring
1
Percentage of complete wound closure for target ulcer