Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the … (NCT07449988) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs
272 participantsStarted 2026-07
Plain-language summary
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 18 years of age or older.
✓. Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.
✓. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
✓. 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 full thickness on the foot or leg without exposed bone.
✓. 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;
✓. TBI ≥ 0.6;
Exclusion criteria
✕. Target ulcers must be treated with compression therapy for at least 14 days prior to enrollment.
✕. The potential subject must consent to using the prescribed compression therapy for the duration of the study.
✕0. The potential subject must agree to attend the weekly study visits required by the protocol.
✕1. The potential subject must be willing and able to participate in the informed consent process.
What they're measuring
1
The percentage of target ulcers achieving complete wound closure