Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins
This study is ongoing, but not recruiting participants.
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00954980
First received: August 5, 2009
Last updated: February 27, 2012
Last verified: August 2011
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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 2012 |
| Estimated 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
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: | February 27, 2012 |
| 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 Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013