TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers

Exclusion Criteria

• •1. Index Ulcer is of non-venous pathophysiology
• •2. Gangrene is present on any part of the affected limb
• •3. Patient is currently receiving dialysis or planning to go on dialysis
• •4. Patient has a glycated hemoglobin A1c (HbA1c) level of \>12%
• •5. Chronic oral steroid use \>7.5 mg daily for longer than 3 months at the time of screening
• •6. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
• •7. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
• •8. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
• •9. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• •10. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• •11. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
• •12. Patient has active malignancy other than non-melanoma skin cancer
• •13. Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
• •14. Patient's random blood sugar is \> 450 mg/dl at screening
• •15. Patient is unable to receive compression therapy as a part of standard of care
• •16. Patient has untreated alcohol or substance abuse at the time of screening
• •17. Pregnant women and women who are breastfeeding
• •18. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
• •19. 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
• •20. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
• •21. Patients who have already been randomized in Protocol 352 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
• •22. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol