Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers

Inclusion Criteria: * Subjects must be at least 18 years of age or older. * Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. * At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area. * 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 on the foot or ankle that does not probe to bone. * Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit: Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg Ankle-Brachial Index (ABI) between 0.7 and 1.3 Peripheral Vascular Resistance (PVR): Biphasic Toe-Brachial Index (TBI) ˃0.6 As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity. * If the 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 subject must consent to using the prescribed off-loading method for the duration of the study. * The subject …