Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers

Exclusion Criteria

• •1. Index Ulcer is of non-diabetic pathophysiology
• •2. Gangrene is present on any part of the affected foot
• •3. Index Ulcer is over an active Charcot deformity
• •4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
• •5. Patient is currently receiving dialysis
• •6. Patient has a glycated hemoglobin A1c (HbA1c) level of \> 12%
• •7. Chronic oral steroid use \> 7.5 mg daily
• •8. Requiring intravenous (IV) antibiotics to treat the index wound infection
• •9. Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
• •10. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
• •11. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• •12. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• •13. Patient has active malignancy other than non-melanoma skin cancer
• •14. Patient's Index Ulcer has decreased by ≥ 30% during 1-week screening period as determined by criteria provided by the Wound Core Lab
• •15. Patient's random blood sugar is \> 450 mg/dl at screening
• •16. Patient has untreated alcohol or substance abuse at the time of screening
• •17. Pregnant women
• •18. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
• •19. Patient has allergy to primary or secondary dressing materials used in this trial
• •20. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies