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

March 30, 2011
April 29, 2011
May 2011
June 2013   (final data collection date for primary outcome measure)
Behavioral Recovery After Varicose Veins (BRAVV) score. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01332838 on ClinicalTrials.gov Archive Site
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
Additional scoring and venous duplex ultrasonography [ Time Frame: 7 and 28 days ] [ Designated as safety issue: No ]
BRAVV at 28 days, Pain score at 7 and 28 days, Bruising score at 7 and 28 days, VCSS at 7 and 28 days, venous duplex ultrasonography at 28 days
Not Provided
Not Provided
 
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Varicose Veins
  • Procedure: Compression stockings
    standard 30to 40 mm Hg thigh high compression stockings
  • Device: compression stockings (Sigvaris )
    Specialized monoleg compression
  • Experimental: Sigvaris special compression stocking
    Intervention: Device: compression stockings (Sigvaris )
  • Active Comparator: Standard Compression
    Intervention: Procedure: Compression stockings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
June 2013
June 2013   (final data collection date for primary outcome measure)

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"
Both
18 Years and older
No
Contact: Linda S Harrison 206-221-3341 lsh3@uw.edu
Contact: Mark H Meissner, MD meissner@uw.edu
United States
 
NCT01332838
COSSCA
Not Provided
Mark Meissner, MD, University of Washington
University of Washington
  • Lake Washington Vascular Associates
  • Sigvaris, Inc
Not Provided
University of Washington
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP