Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft

Exclusion Criteria

• •1. Subject has suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the affected limb. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection).
• •2. Subject has a history of hypersensitivity to bovine collagen and/or chondroitin, as listed in the Dermagraft Directions for Use.
• •3. Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
• •4. Subject cannot be pregnant at the time of treatment.
• •5. Subject was previously treated under this clinical study protocol.
• •6. Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization visit.
• •7. Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with or affect the rate and quality of wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
• •8. Subject has any of the following unstable conditions or circumstances that could interfere with treatment regimen compliance:
• •1. Ability to perform required dressing changes
• •2. Ability to comply with treatment visit schedule
• •3. Mental incapacity
• •4. Current substance abuse
• •9. Subject has excessive lymphedema, which, in the opinion of the Investigator, could interfere with wound healing.
• •10. Subject has unstable Charcot foot or Charcot with boney prominence that, in the opinion of the Investigator, could inhibit wound healing.
• •11. Subject has ulcers secondary to a disease other than diabetes, e.g., vasculitis, neoplasm's, or hematological disorders.
• •12. Subject has osteomyelitis with necrotic soft bone. (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film X-ray.)
• •13. Subject with Chopart amputation.
• •14. 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.
• •15. 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.
• •16. Subject has been treated with hyperbaric oxygen within 5 days of screening.
• •17. 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
• •18. Subject is an employee or relative of any member of the Investigational site or the Sponsor.
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