Back to resultsA Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Primary Purpose
Varicose Veins
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression stockings
compression stockings (Sigvaris )
Sponsored by
About this trial
This is an interventional supportive care trial for Varicose Veins
Eligibility Criteria
Inclusion Criteria:
- Age 18 years and above
- CEAP Class C2 or C3 disease
- Incompetence of the great saphenous vein defined a reflux persisting>0.5 seconds in the upright position
- Planned endovenous ablation of the great saphenous vein
Exclusion Criteria:
- Inability of patient or legal guardian to provide informed consent
- Previous history of DVT
- Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
- Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
- Documented allergy or intolerance to compression stockings
- Arterial insufficiency as documented by an ankle-brachial index <0.5
- Known prothrombotic condition
- Life expectancy less than 1 year
- Inability to return for follow-up due to geographic inaccessibility, concurrent medical conditions or substance abuse
- Weight greater than 220 pounds or height > 6'4"
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sigvaris special compression stocking
Standard Compression
Arm Description
Outcomes
Primary Outcome Measures
Behavioral Recovery After Varicose Veins (BRAVV) score.
Secondary Outcome Measures
Additional scoring and venous duplex ultrasonography
Behavioral Recovery After Varicose Veins (BRAVV) score at 28 days, Pain score at 7 and 28 days, Bruising score at 7 and 28 days, Venous Clinical Severity Score (VCSS) at 7 and 28 days, venous duplex ultrasonography at 28 days
Full Information
NCT ID
NCT01332838
First Posted
March 30, 2011
Last Updated
April 29, 2011
Sponsor
University of Washington
Collaborators
Lake Washington Vascular, Sigvaris, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01332838
Brief Title
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Official Title
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Lake Washington Vascular, Sigvaris, Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sigvaris special compression stocking
Arm Type
Experimental
Arm Title
Standard Compression
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Compression stockings
Intervention Description
standard 30to 40 mm Hg thigh high compression stockings
Intervention Type
Device
Intervention Name(s)
compression stockings (Sigvaris )
Intervention Description
Specialized monoleg compression
Primary Outcome Measure Information:
Title
Behavioral Recovery After Varicose Veins (BRAVV) score.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Additional scoring and venous duplex ultrasonography
Description
Behavioral Recovery After Varicose Veins (BRAVV) score at 28 days, Pain score at 7 and 28 days, Bruising score at 7 and 28 days, Venous Clinical Severity Score (VCSS) at 7 and 28 days, venous duplex ultrasonography at 28 days
Time Frame
7 and 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years and above
CEAP Class C2 or C3 disease
Incompetence of the great saphenous vein defined a reflux persisting>0.5 seconds in the upright position
Planned endovenous ablation of the great saphenous vein
Exclusion Criteria:
Inability of patient or legal guardian to provide informed consent
Previous history of DVT
Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
Documented allergy or intolerance to compression stockings
Arterial insufficiency as documented by an ankle-brachial index <0.5
Known prothrombotic condition
Life expectancy less than 1 year
Inability to return for follow-up due to geographic inaccessibility, concurrent medical conditions or substance abuse
Weight greater than 220 pounds or height > 6'4"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda S Harrison
Phone
206-221-3341
Email
lsh3@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark H Meissner, MD
Email
meissner@uw.edu
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark H Meissner, MD
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
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