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.