Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00954980
First received: August 5, 2009
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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


Condition
Varicose Veins

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Characteristics of Endovenous Sclerotherapy of Varicose Veins

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Frequency of obliteratin (total or partial) of injected varicosity. [ Time Frame: assessment will be at 1, 12, and 26 weeks. ] [ Designated as safety issue: Yes ]
  • Improvement in venous stasis symptoms. [ Time Frame: assessment will be at 1, 12, and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change in quality of life. [ Time Frame: assessment will be at 1, 12, and 26 weeks ] [ Designated as safety issue: Yes ]
  • Associations between clinical outcomes and biomarkers. [ Time Frame: assessment will be at 1, 12, and 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of varicosities. [ Time Frame: assessment will be at 1, 12, and 26 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events reported following procedure. [ Time Frame: assessment will be at 1, 12, and 26 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endovenous Sclerotherapy
For those who have been diagnosed with varicose veins of the leg and have been scheduled to undergo an endovenous sclerotherapy procedure

Detailed Description:

A prospective cohort study of patients who undergo endovenous sclerotherapy over 2 years. There are no deviations in usual clinical assessment and care of patients seeking varicose vein treatment. The purpose of this protocol is only to collect clinical and biomarker information related to this standard treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Clinical diagnosis of varicose veins

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954980

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center campus at the OU Vascular Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Suman W. Rathbun, M.D. Oklahoma University Health Sciences Center
  More Information

No publications provided

Responsible Party: Suman Rathbun, Professor of Medicine, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00954980     History of Changes
Other Study ID Numbers: 14632, 20091634
Study First Received: August 5, 2009
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Varicose Veins
Superficial Thrombophlebitis
Deep Vein Thrombosis
Ulceration
leg pain
leg swelling

Additional relevant MeSH terms:
Varicose Veins
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014