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

August 5, 2009
October 30, 2013
May 2009
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00954980 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins
Evaluation of Clinical Characteristics of Endovenous Sclerotherapy of Varicose Veins

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Probability Sample

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

Varicose Veins
Not Provided
Endovenous Sclerotherapy
For those who have been diagnosed with varicose veins of the leg and have been scheduled to undergo an endovenous sclerotherapy procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of varicose veins

Exclusion Criteria:

  • None
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00954980
14632, 20091634
No
Suman Rathbun, University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Suman W. Rathbun, M.D. Oklahoma University Health Sciences Center
University of Oklahoma
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP