Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

Inclusion Criteria:

• 18 years of age or older.

• Diagnosis of non-healing venous leg ulcer by the following criteria:

  • dependent peripheral edema, dermatitis, hyperpigmentation.
  • an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler.
• Venous Stasis Ulcer is ≥ 2 cm² in size.
• If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.

Exclusion Criteria:

• Subject known to be allergic to Aquacel dressing or components.
• Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
• Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
• Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
• Involvement in another experimental drug trial within the last month.
• Clinical evidence of cellulitis or infection in or around the ulcer.
• History of non-compliance to medical regimens and is not considered reliable.
• Unable to understand the study evaluations and provide a written informed consent.