- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823446
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.
Study Overview
Status
Conditions
Intervention / 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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02908
- Roger Williams Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Normal Saline
|
Sodium Chloride for Irrigation
|
Experimental: Revera Wound Care
|
Revalesio Part Number MDW0060
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
Time Frame: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.
|
CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound edge healing rate
Time Frame: Weekly
|
Weekly
|
Complete Wound Closure
Time Frame: Weekly
|
Weekly
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC 03.1.1.HS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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