A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

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.

Study Overview

• Status: Unknown
• Conditions: Varicose Veins
• Intervention / Treatment: Device: compression stockings (Sigvaris ); Procedure: Compression stockings

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda S Harrison; Phone Number: 206-221-3341; Email: lsh3@uw.edu
• Study Contact Backup: Name: Mark H Meissner, MD; Email: meissner@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington
      • Principal Investigator: Mark H Meissner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sigvaris special compression stocking	Device: compression stockings (Sigvaris ); Specialized monoleg compression
Active Comparator: Standard Compression	Procedure: Compression stockings; standard 30to 40 mm Hg thigh high compression stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Behavioral Recovery After Varicose Veins (BRAVV) score.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Lake Washington Vascular; Sigvaris, Inc

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 8, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: COSSCA