A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

NCT ID: NCT01332838

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sigvaris special compression stocking

Group Type EXPERIMENTAL

compression stockings (Sigvaris )

Intervention Type DEVICE

Specialized monoleg compression

Standard Compression

Group Type ACTIVE_COMPARATOR

Compression stockings

Intervention Type PROCEDURE

standard 30to 40 mm Hg thigh high compression stockings

Interventions

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Compression stockings

standard 30to 40 mm Hg thigh high compression stockings

Intervention Type PROCEDURE

compression stockings (Sigvaris )

Specialized monoleg compression

Intervention Type DEVICE

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lake Washington Vascular

OTHER

Sponsor Role collaborator

Sigvaris, Inc

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Linda S Harrison

Role: CONTACT

206-221-3341

Mark H Meissner, MD

Role: CONTACT

Other Identifiers

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COSSCA

Identifier Type: -

Identifier Source: org_study_id

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