pivotal trial of dermagraft(r) to treat diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: this study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus dermagraft(r). dermagraft is a device containing live human fibroblasts grown on an absorbable vicryl mesh. patients are seen weekly until they heal or the 12-week treatment period is complete.


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.

Keywords: diabetic foot ulcer randomized trial clinical trial dermagraft standard care