Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) 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 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 0.7cm2 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 \<1.3, or TBI of \>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 OCMTM 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