dermagraft(r) for the treatment of patients with diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: this study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus dermagraft(r). dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (vicryl) mesh. patients are evaluated weekly until week 12, then every four weeks until week 32.


Eligibility criteria:
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's care * the study ulcer has healed \<50% in size during the two weeks leading up to randomization * 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 exposure of muscle, tendon, bone, or joint capsule. * the ulcer is free of necrotic debris and clinical infection and is comprised of healthy, 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 must use an acceptable 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. 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 the study. * there is a medical condition(s) that in the investigator's opinion make the patient an inappropriate 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 or cytotoxic agents, or is anticipated to require such agents during the course of the study. * patient has acquired immunodeficiency syndrome (aids) or is infected with human immunodeficiency virus (hiv). * patient has participated in another study utilizing an investigational drug or device within 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 complete this study.

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