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A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332838
Enrollment
20
Registered
2011-04-11
Start date
2011-05-31
Completion date
2013-06-30
Last updated
2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

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.

Interventions

standard 30to 40 mm Hg thigh high compression stockings

DEVICEcompression stockings (Sigvaris )

Specialized monoleg compression

Sponsors

Lake Washington Vascular
CollaboratorOTHER
Sigvaris, Inc
CollaboratorUNKNOWN
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Behavioral Recovery After Varicose Veins (BRAVV) score.7 days

Secondary

MeasureTime frameDescription
Additional scoring and venous duplex ultrasonography7 and 28 daysBehavioral 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

Countries

United States

Contacts

Primary ContactLinda S Harrison
lsh3@uw.edu206-221-3341
Backup ContactMark H Meissner, MD
meissner@uw.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026