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A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

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ClinicalTrials.gov Identifier: NCT01332838
Recruitment Status : Unknown
Verified April 2011 by University of Washington.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2011
Last Update Posted : May 2, 2011
Information provided by:

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.

Condition or disease Intervention/treatment
Varicose Veins Procedure: Compression stockings Device: compression stockings (Sigvaris )

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
Study Start Date : May 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sigvaris special compression stocking Device: compression stockings (Sigvaris )
Specialized monoleg compression
Active Comparator: Standard Compression Procedure: Compression stockings
standard 30to 40 mm Hg thigh high compression stockings

Outcome Measures

Primary Outcome Measures :
  1. Behavioral Recovery After Varicose Veins (BRAVV) score. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Additional scoring and venous duplex ultrasonography [ Time Frame: 7 and 28 days ]
    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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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"
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332838

Contact: Linda S Harrison 206-221-3341 lsh3@uw.edu
Contact: Mark H Meissner, MD meissner@uw.edu

United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Mark H Meissner, MD         
Sponsors and Collaborators
University of Washington
Lake Washington Vascular Associates
Sigvaris, Inc
More Information

Responsible Party: Mark Meissner, MD, University of Washington
ClinicalTrials.gov Identifier: NCT01332838     History of Changes
Other Study ID Numbers: COSSCA
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases