Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.

2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.

3. At randomization subjects must have a target diabetic foot ulcer with a minimumsurface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured postdebridement with manual measurement.

4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52weeks of standard of care prior to the initial screening visit.

5. The target ulcer must be located on the foot with at least 50% of the ulcer belowthe malleolus.

6. The target ulcer must be full thickness on the foot or ankle that does not probe tobone.

7. Adequate circulation to the affected foot as documented by any of the followingmethods performed within 3 months of the first screening visit:

8. TCOM ≥30 mmHg

9. ABI between 0.7 and 1.3

10. PVR: Biphasic

11. TBI ˃0.6

12. As an alternative, arterial Doppler ultrasound can be performed evaluating forbiphasic dorsalis pedis and posterior tibial vessels at the level of the ankle.

13. If the subject has two or more ulcers, they must be separated by at least 2 cm. Thelargest ulcer satisfying the inclusion and exclusion criteria will be designated asthe target ulcer.

14. Target ulcers located on the plantar aspect of the foot must be offloaded for atleast 14 days prior to randomization.

15. The subject must consent to using the prescribed off-loading method for the durationof the study.

16. The subject must agree to attend the weekly study visits required by the protocol.

17. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. A subject known to have a life expectancy of < 6 months is excluded.

2. If the target ulcer is infected or if there is cellulitis in the surrounding skin,the subject is excluded.

3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule oninvestigator's exam or radiographic evidence.

4. Index ulcer and/or index ulcer limb may have had prior infection(s), butinfection(s) must be adequately treated and controlled

5. A subject receiving immunosuppressants (including systemic corticosteroids at dosesgreater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy isexcluded.

6. The topical application of steroids to the ulcer surface within one month of initialscreening is not permitted.

7. A subject with a previous partial amputation on the affected foot is excluded if theresulting deformity impedes proper offloading of the target ulcer.

8. If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken ator within 3 months of the initial screening visit he/she is excluded.

9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomizationhe/she is excluded.

10. The subject is excluded if the surface area measurement of the target ulcer hasreduced in size by more than 30% in the 2 weeks prior to the initial screeningduring the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.

11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedesproper offloading of the target ulcer is excluded.

12. Women who are pregnant or considering becoming pregnant within the next 6 months areexcluded.

13. A potential subject with end stage renal disease requiring dialysis is excluded.

14. A subject who, in the opinion of the Investigator, has a medical or psychologicalcondition that may interfere with study assessments is excluded.

15. Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.