Multicenter, Prospective, Randomized, Controlled Platform Trial Assessing Clinical Utility of Cellular, Acellular and Matrix-like Products (CAMPs) and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers.
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.
• 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:
∙ 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.
• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
⁃ 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.
• Male or female 18 years of age and older.
• Subjects having a non-healing venous leg ulcer of 4 weeks duration, and a maximum of 52 weeks of standard of care (compression), prior to the initial screening visit.
• No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
• At enrollment (TV1) Subjects' wound size is a minimum of 1 cm2 and maximum of 20 cm2 as measured post-debridement with the MolecuLight® imaging device.
• 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;
‣ 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 compression 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.