Clinical Research Directory

Inclusion Criteria 1. Ambulatory patients ≥ 50 and ≤ 85 years of age; 2. Willing and able to provide informed consent; 3. Willing and able to comply with study requirements; 4. Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus 5. If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study; 6. Index ulcer is able to be visualized and accurately measured with eKare Insights; 7. Non-study ulcers must be \> 2 cm (.79 in.) from the index ulcer; 8. Index DFU identified ≥ 4 weeks prior to study screening and \< 52 weeks from the date of informed consent; 9. Index DFU area \> 1.0 cm2 (0.39 in.) and \< 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1; 10. Index DFU offloaded according to SOC for entire run-in period, prior to randomization; 11. Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist/direct the patient in the pre-screening period to obtain a PCP). 12. Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening: A. ABI ≥ 0.7 and ≤ 1.3 AND TBI \> 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg; C. Arterial duplex with biphasic flow in BOTH the DP and PT arteries verified by PI and documented. Exclusion Criteria 1. Index foot ulcer documented to be caused by a medical condition other than diabetes; 2. Potential subject has five (5) or more DFUs and/or VLUs in the target limb; 3. DFU is secondary to Charcot neuroarthropathy; 4. Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening; 5. Index ulcer is potentially or confirmed by biopsy to be cancerous; 6. Index ulcer site has undergone radiation therapy; 7. Venous leg ulcers in diabetic patients; 8. Active infection proximal to or at site of index ulcer; 9. Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period; 10. Presence of active osteomyelitis or bone infection as verified by x-ray /MRI within 30 days of visit #1 of the run-in period; 11. Raynaud's disease; 12. Unreconstructible arterial ischemia which may lead to nonhealing; 13. Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation; 14. Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation; 15. Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation; 16. Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period; 17. Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period; 18. Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period; 19. Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies: 1. Biomedical or topical growth factor; 2. Topical steroids applied to the index ulcer surface; 3. On medications that are considered immune system modulators that could affect graft incorporation; 4. Scarlet red dressing; 5. Dakin's solution; 6. Mafenide acetate; 7. Tincoban; 8. Zinc sulfate; 9. Povidone-iodine solution; 10. Polymyxin/nystatin; 11. Chlorhexidine; 20. Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi); 21. Patient has serum creatinine \> 2.5 mg/dL within 30 days of study wound management visit #1 of the run-in period; 22. Autoimmune connective tissue disease; 23. End stage renal disease (ESRD); 24. Presence of any condition which would seriously compromise the subject's ability to complete this study; 25. Known history of poor adherence to medical therapy and/or clinic appointments; 26. Pregnant, or planning to become pregnant during the study; 27. Life expectancy \< 1 year.