A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
• The potential subject must be at least 18 years of age or older.
• The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
• The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
• The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
• The potential subject must have a 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.
• The potential 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;
⁃ TBI ≥ 0.6;
⁃ TCOM ≥ 40 mmHg;
⁃ PVR: biphasic.
• If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• The potential subject must consent to using the prescribed offloading method for the duration of the study.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject must be at least 21 years of age or older.
• At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
• The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.
• The potential 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;
⁃ TBI ≥ 0.6;
⁃ TCOM ≥ 40 mmHg;
⁃ PVR: biphasic.
• If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.