A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Washington.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Lake Washington Vascular Associates
Sigvaris, Inc
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01332838
First received: March 30, 2011
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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 Intervention
Varicose Veins
Procedure: Compression stockings
Device: compression stockings (Sigvaris )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Behavioral Recovery After Varicose Veins (BRAVV) score. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional scoring and venous duplex ultrasonography [ Time Frame: 7 and 28 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332838

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

Locations
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

No publications provided

Responsible Party: Mark Meissner, MD, University of Washington
ClinicalTrials.gov Identifier: NCT01332838     History of Changes
Other Study ID Numbers: COSSCA
Study First Received: March 30, 2011
Last Updated: April 29, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014