Back to resultsFeasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
Primary Purpose
Venous Stasis Ulcers
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Revera Wound Care
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Venous Stasis Ulcers
Eligibility Criteria
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.
Sites / Locations
- Roger Williams Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Revera Wound Care
Normal Saline
Arm Description
Outcomes
Primary Outcome Measures
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
Secondary Outcome Measures
Wound edge healing rate
Complete Wound Closure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00823446
Brief Title
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revalesio Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Revera Wound Care
Arm Type
Experimental
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Revera Wound Care
Intervention Description
Revalesio Part Number MDW0060
Intervention Type
Device
Intervention Name(s)
Normal Saline
Intervention Description
Sodium Chloride for Irrigation
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Wound edge healing rate
Time Frame
Weekly
Title
Complete Wound Closure
Time Frame
Weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Roger Williams Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
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