Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment

Exclusion Criteria

• •1. Patients with ABPI \<0.7.
• •2. Clinical signs of infection requiring treatment. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after resolution of the infection).
• •3. Taking systemic antibiotics, steroids or immunosuppressive drugs.
• •4. History of poor compliance.
• •5. Bedridden.
• •6. Arterial or mixed etiology ulcers.
• •7. Severe diabetic peripheral neuropathy.
• •8. DVT in the last month.
• •9. Participation in another clinical investigations in the month prior to recruitment.
• •10. Poorly controlled hypertension.
• •11. Coronary artery disease.
• •12. Malignancy, respiratory or cardiac failure.
• •13. Autoimmune disease.
• •14. Liver (elevated enzymes)or kidney disease (elevated serum creatinine).
• •15. Gangrene of the affected limb.
• •16. Subject has suspected or confirmed signs/symptoms of gangrene or 5 wound infection on any part of the affected limb.
• •17. Subject has a history of hypersensitivity to any of the material used in the compression dressing
• •18. Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
• •19. Subject was previously treated under this clinical study protocol.
• •20. Cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
• •21. Subject has osteomyelitis (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film Xray.)
• •22. Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
• •23. Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.
• •24. Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:
• •1. End-stage renal disease
• •2. Immunosuppression
• •3. Severe malnutrition
• •4. Liver disease
• •5. Aplastic anemia
• •6. Scleroderma
• •7. Acquired immune deficiency syndrome (AIDS) or HIV positive
• •8. Connective tissue disorder
• •9. Exacerbation of sickle cell anemia
• •25. Subject is an employee or relative of any member of the Investigational site or the Sponsor.
• •26. Subject is diabetic, HbA1c not to exceed 10% at time of enrollment.
• •27. COPD -