Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

Inclusion Criteria: * Patient is 18 years of age or older. * Patient has type I or II diabetes. * Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care. * Foot ulcer is on the plantar surface of the forefoot or heel. * Ulcer size is \>/=1.0 cm2 at Day 0 (day of randomization). * Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule. * Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue. * Patient's Ankle-Arm Index by Doppler is \>/=0.7. * Patient has adequate circulation to the foot as evidenced by a palpable pulse. * Female patients of child bearing potential must not be pregnant and must use accepted 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 before treatment. * Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit. Exclusion Criteria: * There is clinical evidence of gangrene on any part of the affected foot. * The study ulcer is over a Charcot deformity. * The study ulcer is due to a nondiabetic etiology. * The ulcer has tunnels or sinus tracts that cannot be completely debrided. * The ulcer is \>20 cm2 (longest dimension cannot be greater than 5 cm). * The ulcer has increased or decreased in size by 50% or more during the screening period. * Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study. * Presence of a malignant disease not in remission for 5 years or more. * Evidence of severe malnutrition, based on a serum albumin level \<2.0. * Presence of patient having known alcohol or drug abuse. * A random blood sugar reading \>/=450 mg/dL. * Presence of urine ketones that are noted to be "Small, Moderate, or Large". * Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0. * Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study. * A history of bleeding disorder. * Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV). * Participation in another study involving treatment with an investigational product within the previous 30 days. * Elective osseous procedures to the study foot within 30 days prior to the Screening visit. * Previous treatment with Dermagraft®. * Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection. * Presence of condition(s) that seriously compromise the patient's ability to complete this study.