Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Inclusion Criteria: * \>18 years of age * ABI \> 0.80 * Three or fewer venous leg ulcers, if multiple must be separated by 2 cm * Ultrasound demonstrates venous reflux \>0.5 seconds * Study wound present for 1-24 months * Study wound 2-15 sq cm surface area * Clean, granulating wound * Patient able and willing to sign informed consent and comply with study procedures. * Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test. Exclusion Criteria: * Wound etiology uncertain or not from venous hypertension. * BMI\>40 * Acute or chronic infectious skin disease * Allergy or intolerance to Profore(R) * Wound infection, cellulitis, osteomyelitis * \>2 weeks' treatment with immunosuppressive agents in recent past * Investigational drug use within 30 days * Severe malnutrition, drug and/or alcohol abuse * Malignant disease unless in remission for 5 years * History of radiation at the study site * Other conditions that could impede wound healing * Known history of HIV or AIDS * Prior participation in any Dermagraft study * Treatment with other bioengineered tissue products within 30 days * Unable to understand the aims and objectives of the trial * Inability to comply with study protocol * NYHA Class III or IV CHF * Uncontrolled diabetes mellitus * Dorsal foot ulcer