Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to… (NCT06449638) | Clinical Trial Compass
RecruitingNot Applicable
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
United States272 participantsStarted 2024-07-16
Plain-language summary
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Who can participate
Age range18 Years
SexALL
See this in plain English?
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.
✓. Diagnosis of type 1 or 2 Diabetes mellitus.
✓. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 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 located on the foot with at least 50% of the ulcer below the malleolus.
✓. The target ulcer must be full thickness 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:
✓. Ankle-Brachial Index (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
The percentage of target ulcers achieving complete wound closure