A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
This study is not yet open for participant recruitment.
Verified April 2011 by University of Washington
Sponsor:
University of Washington
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
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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
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 May 16, 2013