SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

Inclusion Criteria: * At least 18 years of age. * Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy. * Presence of a DFU Wagner 1 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. \[NOTE: DFU must maintain Wagner 1 Grade for the duration of study run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).\] * If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.\] * Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥28 days) prior to the initial screening visit (SV1). * Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 15 cm2 at first screening visit (SV1) and first randomization visit (RV1). * Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) of ≥ 0.7 and ≤ 1.2, or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75, using the affected study extremity within 30 days of screening visit (SV1). * Index ulcer and/or index ulcer limb may have had prior infection(s), but …