Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Exclusion Criteria

• •1. Subject is unable to comply with protocol treatment
• •2. Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
• •3. Wagner 3, 4, or 5 involving tendon, bone, or joint.
• •4. Presence of systemic infection, sepsis, or osteomyelitis at screening.
• •5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
• •6. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.
• •7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
• •8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
• •9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
• •10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
• •11. Subject is pregnant or breastfeeding
• •12. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study
• •13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
• •14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator