A Comparison of Specialized Versus Standard Compression A... | NCT01332838

Studies
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

NCT01332838

Sponsor

University of Washington

Status

Unknown status

Last Update Posted

May 2, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Varicose Veins

Interventions

Compression stockings
compression stockings (Sigvaris )

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Mar 30, 2011

First Submission Date that Met QC Criteria

Apr 8, 2011

First Posted Date

Apr 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Name	Class
Lake Washington Vascular	OTHER
Sigvaris, Inc	UNKNOWN

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sigvaris special compression stocking	Experimental		Device: compression stockings (Sigvaris )
Standard Compression	Active Comparator		Procedure: Compression stockings

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Compression stockings	Procedure	standard 30to 40 mm Hg thigh high compression stockings	Standard Compression

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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"

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linda S Harrison	Contact	206-221-3341		lsh3@uw.edu
Mark H Meissner, MD	Contact			meissner@uw.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98105	United States

Type	Date	Date Unknown
Release	Oct 24, 2016
Reset	Dec 15, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 24, 2016			Dec 15, 2016

Condition Browse Module

MeSH Terms

ID	Term
D014648	Varicose Veins

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053828	Stockings, Compression

Ancestor Terms

ID	Term
D058128	Compression Bandages
D001458	Bandages
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided