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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.

Conditions
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Venous Stasis Ulcers

Intervention / Treatment
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* Device: Revera Wound Care
* Device: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revera Wound Care<br> | Device: Revera Wound Care<br>* Revalesio Part Number MDW0060<br>|
| Placebo Comparator: Normal Saline<br> | Device: Normal Saline<br>* Sodium Chloride for Irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet. |  | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Wound edge healing rate |  | Weekly | 
| Complete Wound Closure |  | Weekly |