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

Completed · Phase 1

Conditions studied: Venous Stasis Ulcers

In brief

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

Key facts

Study ID

NCT00823446

Run by

Revalesio Corporation

People needed

13

Starts

2008-03-01

Expected to finish

2010-10-01

Last updated by the study team

2012-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Roger Williams Medical Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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