A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMay 2, 2011
April 1, 2011
2.1 years
March 30, 2011
April 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Behavioral Recovery After Varicose Veins (BRAVV) score.
7 days
Secondary Outcomes (1)
Additional scoring and venous duplex ultrasonography
7 and 28 days
Study Arms (2)
Sigvaris special compression stocking
EXPERIMENTALStandard Compression
ACTIVE COMPARATORInterventions
standard 30to 40 mm Hg thigh high compression stockings
Specialized monoleg compression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Lake Washington Vascularcollaborator
- Sigvaris, Inccollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 11, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
May 2, 2011
Record last verified: 2011-04