Clinical Research Directory

Inclusion Criteria: 1. \>18 years of age 2. Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema) 3. have a venous ulcer between the knee and ankle, at or above the malleolus 4. wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone 5. wound duration of at least 6 months 6. VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue 7. ability of subject to tolerate limb compression bandage 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