A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

University of Washington

Status: Unknown

Conditions: Varicose Veins

Treatments: Procedure: Compression stockings; Device: compression stockings (Sigvaris )

Study type: Interventional

Funder types: Other

Identifiers

NCT01332838

COSSCA

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sigvaris special compression stocking

Experimental group

Treatment:

Device: compression stockings (Sigvaris )

Standard Compression

Active Comparator group

Treatment:

Procedure: Compression stockings