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

This is an interventional treatment trial for Chronic Venous Hypertension With Ulcer Read More

Inclusion Criteria:Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.

1. Adult patients with venous leg ulcer(s) >1 month.
2. A signed and dated informed consent form.
3. Subject is able to comply with instructions and scheduled visits, not confined to bed,.
4. Ulcer surface area >2cm2 but not >10cm in any dimension. The total not to exceed 18cm2
5. ABPI >.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator.
6. There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator..
7. Casual smoker not exceeding one pack per week -

Exclusion Criteria:Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

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 -