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

Launched by ORGANOGENESIS · Aug 12, 2010

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Eligibility criteria

• 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.