Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

Inclusion Criteria:

1. Male or Female, 18 years of age or older

2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiringoral or glycemic control and/or insulin replacement therapy

3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented inmedical record), and less than 12 months duration if being treated with continuousSOC

4. Subject has a diabetic foot ulcer with a historical wound measurement showing lessthan 25% healing in 14 days prior to screening

5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization

6. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection orclinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acuteosteomyelitis and the subject has successfully completed IV antibiotic treatmentprior to screening.

7. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit

8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior torandomization

9. Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization OR an arterial ultrasound noted withpatent circulation and without significant stenosis 90 days prior to randomization.

10. Index ulcer is free of infection prior to randomization and during screening phase.Infection must be adequately treated and controlled as defined by Infectious DiseaseSociety of America (IDSA) Guidelines PEDIS Grade 1.

11. Index ulcer is free of necrotic debris prior to NeoThelium FT application

12. Female subjects of childbearing potential having a negative pregnancy test prior torandomization

13. Subject is able and willing to follow the protocol requirements

14. Subject had signed informed consent

15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

1. Subject has a known life expectance of <1 year

2. Subject is unable to comply with protocol treatment

3. Subject has major uncontrolled medical disorders in the opinion of the investigator,such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliativecare, or inherited blood disorders that may affect wound healing

4. Subject actively being treated for malignant disease or history of malignancy orradiation therapy at the site of wound

5. Subject has comorbid conditions that may compromise subject safety in the opinion ofthe investigator

6. Known contraindications to tissue-engineered allograft

7. Concurrent participation in alternative clinical trial that involves investigationaldrug or device interfering with wound treatment and/or healing

8. Subject is pregnant or breastfeeding

9. Subject with history of immunosuppressant treatment (systemic corticosteroids >10mgdaily dose), cytotoxic chemotherapy, or topical steroid application to the ulcersurface for >2 weeks duration within 30 days prior to randomization; or anticipateduse of the above during the course of the study

10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization

11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has notcompleted IV antibiotic treatment, or Wagner 3 grade with chronic refractoryosteomyelitis

12. Wound depth with visible exposed bone

13. HBOT within 14 days prior to randomization

14. Revascularization surgery on the index ulcer leg within 30 days of screening phase

15. Index ulcer suspicious of neoplasm in the opinion of the principal investigator