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

This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating 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 requiring oral or glycemic control and/or insulin replacement therapy 3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC 4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 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 or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior 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 to randomization 9. Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent 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 Disease Society 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 to randomization 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 \10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use 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 not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis 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