TruSkin®: Study for the Treatment of 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 a Charcot deformity
• •4. Patient is currently receiving dialysis or planning to go on dialysis
• •5. Patient has a glycated hemoglobin A1c (HbA1c) level of \>12%
• •6. Chronic oral steroid use \>7.5 mg daily for longer than 3 months at the time of screening
• •7. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
• •8. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
• •9. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
• •10. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• •11. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• •12. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
• •13. Patient has active malignancy other than non-melanoma skin cancer
• •14. Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
• •15. Patient's random blood sugar is \> 450 mg/dl at screening
• •16. Patient is unable to properly off-load the index wound as a part of standard of care
• •17. Patient has untreated alcohol or substance abuse at the time of screening
• •18. Pregnant women and women who are breastfeeding
• •19. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
• •20. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
• •21. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
• •22. Patients who have already been randomized in Protocol 351 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
• •23. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol