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