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

Exclusion Criteria

• •Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
• •Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening visit (SV1).
• •Index ulcer in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
• •Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment).
• •Subjects with exposed internal fixation on the same limb as the index ulcer \[NOTE: External fixation is allowed if deemed stable by principal investigator.\]
• •Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1). \[NOTE: NPWT is allowed up to the day of screening (SV1), if in the opinion of the Principal Investigator NPWT may be discontinued.\]
• •Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol.
• •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within 30 days prior to first screening visit (SV1), or who receive such medications during the run-in period, or who are anticipated to require such medications during the study.
• •Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
• •In the opinion of the Investigator, the subject is non-compliant with offloading or index ulcer dressing during the run-in period.
• •Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
• •Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
• •Subject is pregnant or breast-feeding.
• •Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days prior to randomization (RV1).
• •Subjects with end stage renal disease requiring treatment with dialysis and/or evident by an eGFR \<30 mL/min/1.73m2 within 120 days of randomization (RV1). \[NOTE: Subjects with two documented eGFR values within 120 days, the most recent value may be used if the eGFR ≥30 mL/min/1.73m2 and is, in the opinion of the principal investigator, stable and the subject will not require treatment with dialysis for the duration of study participation.\]
• •Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit.
• •Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at screening (SV1).
• •Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening (SV1).
• •Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation. \[NOTE: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial.\]
• •Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.