Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

Exclusion Criteria

• •Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
• •1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
• •2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
• •3. Index ulcer is infected
• •4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
• •5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
• •6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
• •7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
• •8. Subjects with a previous diagnosis of HIV or Hepatitis C
• •9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
• •10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
• •11. Subject is pregnant or breast-feeding
• •12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
• •13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
• •14. Presence of acute Charcot Neuroarthropathy to the affected limb
• •15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit