A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

Not Applicable

• Conditions: Varicose Veins
• Interventions: Device: compression stockings (Sigvaris ); Procedure: Compression stockings

• Registration Number: NCT01332838
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-30
• Status Verified: 2011-04
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Last Update Submitted: 2011-04-29
• Study Start: 2011-05
• Last Update Posted: 2011-05-02
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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"

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sigvaris special compression stocking	compression stockings (Sigvaris )	-
Standard Compression	Compression stockings	-

Primary Outcome Measures

Name	Time	Method
Behavioral Recovery After Varicose Veins (BRAVV) score.	7 days

Secondary Outcome Measures

Name	Time	Method
Additional scoring and venous duplex ultrasonography	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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States