Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

Inclusion Criteria:

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

2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manualmeasure.

3. 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.

4. 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.

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

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

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

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

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

10. TCOM ≥30 mmHg

11. ABI between 0.7 and 1.3

12. PVR: Biphasic

13. TBI ˃0.6

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

15. 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.

16. Target ulcers must have been treated with compression therapy for at least 14 daysprior to randomization.

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 leg is excluded if theresulting deformity impedes proper offloading of the target ulcer.

8. If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equalto 12% taken at or within 3 months of the initial screening visit he/she isexcluded.

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

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

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

14. A 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