NCT00954980

Brief Summary

The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

3.6 years

First QC Date

August 5, 2009

Last Update Submit

November 2, 2016

Conditions

Varicose Veins

Keywords

Varicose VeinsSuperficial ThrombophlebitisDeep Vein ThrombosisUlcerationleg painleg swelling

Outcome Measures

Primary Outcomes (4)

  • Frequency of obliteratin (total or partial) of injected varicosity.

    assessment will be at 1, 12, and 26 weeks.

  • Improvement in venous stasis symptoms.

    assessment will be at 1, 12, and 26 weeks

  • Change in quality of life.

    assessment will be at 1, 12, and 26 weeks

  • Associations between clinical outcomes and biomarkers.

    assessment will be at 1, 12, and 26 weeks

Secondary Outcomes (2)

  • Recurrence of varicosities.

    assessment will be at 1, 12, and 26 weeks

  • Adverse events reported following procedure.

    assessment will be at 1, 12, and 26 weeks

Study Arms (1)

Endovenous Sclerotherapy

For those who have been diagnosed with varicose veins of the leg and have been scheduled to undergo an endovenous sclerotherapy procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Vascular or primary care clinic patients who have been scheduled to undergo an endovenous sclerotherapy procedure

You may qualify if:

  • Clinical diagnosis of varicose veins

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center campus at the OU Vascular Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples will be obtained for measurement of D-dimer, fibrin monomer, and total microparticles.

MeSH Terms

Conditions

Varicose VeinsVenous ThrombosisUlcer

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesThrombosisEmbolism and ThrombosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suman W. Rathbun, M.D.

    Oklahoma University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2012

Study Completion

July 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

US(1)