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'scare

• The study ulcer has healed <50% in size during the two weeks leading up torandomization

• 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 exposureof muscle, tendon, bone, or joint capsule.

• The ulcer is free of necrotic debris and clinical infection and is comprised ofhealthy, 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 mustuse an acceptable means 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.

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 thestudy.

• There is a medical condition(s) that in the Investigator's opinion make the patient aninappropriate 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 orcytotoxic agents, or is anticipated to require such agents during the course of thestudy.

• Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with HumanImmunodeficiency Virus (HIV).

• Patient has participated in another study utilizing an investigational drug or devicewithin 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 completethis study.