Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.

Exclusion Criteria

• •9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• •10. The subject must consent to using the prescribed off-loading method for the duration of the study.
• •11. The subject must agree to attend the weekly study visits required by the protocol.
• •12. The subject must be willing and able to participate in the informed consent process.
• •Subjects will be excluded from participation in the study if any of the following conditions exist:
• •1. A subject known to have a life expectancy of \< 6 months is excluded.
• •2. The subject is excluded if the target ulcer is not secondary to diabetes.
• •3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• •4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• •5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• •6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• •7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• •8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• •9. If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit he/she is excluded.
• •10. The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the subject received SOC.
• •11. A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
• •12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• •13. A potential subject with end stage renal disease requiring dialysis is excluded.
• •14. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
• •15. A subject who in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• •16. 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.