Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Exclusion Criteria

• •Patient has clinical evidence of gangrene on any part of the affected foot.
• •The ulcer is over a Charcot deformity.
• •The ulcer has a nondiabetic etiology.
• •The ulcer has tunnels or sinus tracts that cannot be completely debrided.
• •The patient's diabetes is uncontrolled and could interfere with the completion of the study.
• •There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study.
• •Patient has/had a malignant disease not in remission for 5 years or more.
• •Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of \<2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range.
• •Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
• •Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV).
• •Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
• •The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection.
• •Patient has any condition(s) which seriously compromises their ability to complete this study.