Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Exclusion Criteria

• •1. Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
• •2. Patient is pregnant, breast feeding or planning to become pregnant
• •3. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
• •4. Patient has a life expectancy less than six months as assessed by the investigator
• •5. Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
• •6. Patient has an additional wound within 3 cm of the study wound
• •7. Hgb A1c \> 12% within 3 months prior to randomization in patients with a known history of diabetes
• •8. Patient not in reasonable metabolic control in the judgment of the investigator
• •9. Patient with a known history of poor compliance with medical treatments
• •10. Patient currently undergoing cancer treatment
• •11. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
• •12. Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is \< 10 mg per day for prednisone.
• •13. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
• •14. Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
• •15. Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
• •16. Study ulcer spontaneously closes during the 2-week run in period