Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Exclusion Criteria

• •1. history of diabetes mellitus and a HbA1c \> 12% (obtained within past 6 months)
• •2. Ankle brachial index(ABI) less than 0.80
• •3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
• •4. suspicion of malignancy within VLU
• •5. life expectancy \<6 months
• •6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
• •7. history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) \>2x upper limit of normal (obtained within past 6 months)
• •8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
• •9. history of immunodeficiency
• •10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology
• •11. Untreated osteomyelitis
• •12. Hepatitis
• •13. acute deep venous thrombosis
• •14. allergy to lidocaine and/or epinephrine
• •15. Subject's inability to successfully tolerate compression therapy that is changed weekly
• •16. Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
• •17. if currently incarcerated
• •18. known pregnancy