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Chapel Hill, North Carolina 27514


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.


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.



Primary Contact:

Principal Investigator
William A Marston, MD
University of North Carolina School of Medicine, Chapel Hill, NC

Backup Contact:


Location Contact:

Chapel Hill, North Carolina 27514
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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