Inclusion Criteria:

• This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both.
• Patients must be 18 years old or more.
• The VSU size must be in the range 1-64 cm2.
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
• The VSU must have been present for more than 1 month.
• The ulcer must be located between and including the knee and ankle.
• The wound bed must have viable tissues with granulation tissue.

Exclusion Criteria:

• Exposed bone, tendon, or fascia.
• Severe rheumatoid arthritis.
• History of radiotherapy to the ulcer site.
• Uncontrolled congestive heart failure.
• Receiving corticosteroids or immune suppressives.
• History of collagen vascular disease.
• Known malnutrition (albumin < 2.5 g/dL). If malnutrition is suspected by the principal investigator, the albumin level should be checked to determine whether the patient meets the albumin criterion.
• Ulcer clinically infected at the time of entry into the study. However, patients may be entered into the study after successful treatment of infection.
• Known uncontrolled diabetes (HgbA1c > 12%). If the principal investigator suspects uncontrolled diabetes, the Hgb A1c should be checked to determine patient eligibility.
• Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
• Known arterial insufficiency (Ankle-brachial index < 0.7, or TCPO2 < 35 mmHg, or Toe brachial index < 0.4). If the principal investigator suspects uncontrolled diabetes, the Ankle-brachial index should be checked to determine patient eligibility.
• Active sickle cell disease.
• Unable to comply with the procedures described in the protocol.
• Enrolled in a clinical evaluation for another investigational wound-care device or drug.
• Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months.
• Pregnancy, suspected or confirmed.
• History of peripheral vascular disease, or chronic renal disease.
• Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy.
• History of pulmonary embolism.
• Poorly controlled asthma.
• Use of Apligraf, skin graft or similar biological dressing within 30 days of study entry.
• Patients with concurrent atrophie blanche.