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.
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 13, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 26, 2012
June 1, 2012
2.6 years
January 13, 2009
June 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Wound edge healing rate
Weekly
Complete Wound Closure
Weekly
Study Arms (2)
Revera Wound Care
EXPERIMENTALNormal Saline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2009
First Posted
January 15, 2009
Study Start
March 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 26, 2012
Record last verified: 2012-06