Status:
COMPLETED
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
Lead Sponsor:
Revalesio Corporation
Conditions:
Venous Stasis Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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. This evaluation will be done ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00823446
Start Date
March 1 2008
End Date
October 1 2010
Last Update
June 26 2012
Active Locations (1)
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1
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908