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'scare.

• 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 ofmuscle, tendon, bone, or joint capsule.

• Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appearsto 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 acceptedmeans of birth control.

• Patient and caregiver are willing to participate in the clinical study and can complywith the follow-up regimen.

• Patient or his/her legal representative has read and signed the Institutional ReviewBoard (IRB) approved Informed Consent form before treatment.

• Patient's study ulcer has been present (open) for at least 6 weeks at the time of theScreening 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 screeningperiod.

• Presence of medical condition(s) that in the Investigator's opinion makes the patientan 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

• 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 productwithin the previous 30 days.

• Elective osseous procedures to the study foot within 30 days prior to the Screeningvisit.

• Previous treatment with Dermagraft®.

• Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence ofinfection.

• Presence of condition(s) that seriously compromise the patient's ability to completethis study.