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

Inclusion Criteria: * Patient is 18 years old or older. * Patient has a current diagnosis of NIDDM or IDDM. * Patient's ulcer is present for a minimum of two weeks under the current Investigator's care * The study ulcer has healed \<50% in size during the two weeks leading up to randomization * The study ulcer is on the plantar surface of the forefoot * The ulcer is \>/= 1.0 cm2 at Day 0 (the day of randomization). * The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule. * The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting. * The patient's Ankle-Arn Index by Doppler is \>0.1 * There is adequate circulation to the foot to allow for healing. * The patient's diabetes is under control as determined by the Investigator. * Female patients capable of bearing children must test negative for pregnancy and must use an acceptable means of birth control. * Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen. * Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form. 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.