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NCT01332838 Clinical Trial

A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

Varicose Veins Clinical Trial

Official title:
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01332838
Other study ID # COSSCA
Secondary ID
Status Unknown status
Phase N/A
First received March 30, 2011
Last updated April 29, 2011
Start date May 2011
Est. completion date June 2013

Study information
Verified date April 2011
Source University of Washington
Contact Linda S Harrison
Phone 206-221-3341
Email lsh3@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 20
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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"

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Compression stockings
standard 30to 40 mm Hg thigh high compression stockings
Device:
• compression stockings (Sigvaris )
Specialized monoleg compression

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (3)
Lead Sponsor Collaborator
University of Washington Lake Washington Vascular Associates, Sigvaris, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Behavioral Recovery After Varicose Veins (BRAVV) score. 7 days
Secondary Additional scoring and venous duplex ultrasonography 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 7 and 28 days
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