Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
NCT ID: NCT00823446
Last Updated: 2012-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2008-03-31
2010-10-31
Brief Summary
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Detailed Description
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This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.
The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.
This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Revera Wound Care
Revera Wound Care
Revalesio Part Number MDW0060
Normal Saline
Normal Saline
Sodium Chloride for Irrigation
Interventions
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Revera Wound Care
Revalesio Part Number MDW0060
Normal Saline
Sodium Chloride for Irrigation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Revalesio Corporation
INDUSTRY
Responsible Party
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Locations
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Roger Williams Medical Center
Providence, Rhode Island, United States
Countries
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Other Identifiers
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RC 03.1.1.HS1
Identifier Type: -
Identifier Source: org_study_id
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