Varicose VeinsNCT00954980
Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins
An observational study of Varicose Veins, run by University of Oklahoma at 1 site in United States.
Trial summary
The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vascular or primary care clinic patients who have been scheduled to undergo an endovenous sclerotherapy procedure
Who may be able to join
- Clinical diagnosis of varicose veins
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center campus at the OU Vascular Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins, Superficial Thrombophlebitis, Deep Vein Thrombosis, Ulceration, leg pain, leg swelling
- Medical subject headings
- Varicose Veins, Venous Thrombosis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endovenous Sclerotherapy | For those who have been diagnosed with varicose veins of the leg and have been scheduled to undergo an endovenous sclerotherapy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of obliteratin (total or partial) of injected varicosity.
Measured: assessment will be at 1, 12, and 26 weeks.
Improvement in venous stasis symptoms.
Measured: assessment will be at 1, 12, and 26 weeks
Change in quality of life.
Measured: assessment will be at 1, 12, and 26 weeks
Associations between clinical outcomes and biomarkers.
Measured: assessment will be at 1, 12, and 26 weeks
Secondary outcomes (2)
Recurrence of varicosities.
Measured: assessment will be at 1, 12, and 26 weeks
Adverse events reported following procedure.
Measured: assessment will be at 1, 12, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suman Rathbun, University of Oklahoma
- Investigators
- Suman W. Rathbun, M.D., Principal investigator, Oklahoma University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954980
- Sponsor's protocol ID
- 14632
- Other IDs
- 20091634
- Status last verified
- Nov 2016
- First submitted
- 5 Aug 2009
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Characteristics of Endovenous Sclerotherapy of Varicose Veins
- ClinicalTrials.gov ID
- NCT00954980
- Acronym / sponsor ID
- 14632
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins, Superficial Thrombophlebitis, Deep Vein Thrombosis, Ulceration, leg pain, leg swelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovenous Sclerotherapy | – | –For those who have been diagnosed with varicose veins of the leg and have been scheduled to undergo an endovenous sclerotherapy procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vascular or primary care clinic patients who have been scheduled to undergo an endovenous sclerotherapy procedure
Key inclusion criteria (1 listed)
- Clinical diagnosis of varicose veins
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of obliteratin (total or partial) of injected varicosity.
Time frame: assessment will be at 1, 12, and 26 weeks.
Improvement in venous stasis symptoms.
Time frame: assessment will be at 1, 12, and 26 weeks
Change in quality of life.
Time frame: assessment will be at 1, 12, and 26 weeks
Associations between clinical outcomes and biomarkers.
Time frame: assessment will be at 1, 12, and 26 weeks
2 secondary outcomes
Recurrence of varicosities.
Time frame: assessment will be at 1, 12, and 26 weeks
Adverse events reported following procedure.
Time frame: assessment will be at 1, 12, and 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman W. Rathbun, M.D. principal investigator
Oklahoma University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of obliteratin (total or partial) of injected varicosity. (time frame: assessment will be at 1, 12, and 26 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.