Varicose VeinsNCT01332838
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
A study testing Compression stockings and compression stockings (Sigvaris ) in people with Varicose Veins, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Compression stockings and compression stockings (Sigvaris )
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2013
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- CEAP Class C2 or C3 disease
- Incompetence of the great saphenous vein defined a reflux persisting>0.5 seconds in the upright position
- Planned endovenous ablation of the great saphenous vein
Who cannot join
- Inability of patient or legal guardian to provide informed consent
- Previous history of DVT
- Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
- Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
- Documented allergy or intolerance to compression stockings
- Arterial insufficiency as documented by an ankle-brachial index <0.5
Show all 10Show fewer
- Known prothrombotic condition
- Life expectancy less than 1 year
- Inability to return for follow-up due to geographic inaccessibility, concurrent medical conditions or substance abuse
- Weight greater than 220 pounds or height > 6'4"
Trial locations and contacts
1 site in 1 country.
Mark H Meissner, MD contact
United States1 site
University of Washington
Seattle, Washington, 98105
Mark H Meissner, MD
About this study
The purpose of this study is to determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation.
- Conditions
- Varicose Veins
- Being tested
- Compression stockings, compression stockings (Sigvaris )
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingsProcedure or surgery
standard 30to 40 mm Hg thigh high compression stockings
compression stockings (Sigvaris )Device
Specialized monoleg compression
| Study group | Role | What they receive |
|---|---|---|
| Sigvaris special compression stocking | Experimental | Not described Receives: Device: compression stockings (Sigvaris ) |
| Standard Compression | Active comparator | Not described Receives: Procedure: Compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Recovery After Varicose Veins (BRAVV) score.
Measured: 7 days
Secondary outcomes (1)
Additional scoring and venous duplex ultrasonography
Behavioral Recovery After Varicose Veins (BRAVV) score at 28 days, Pain score at 7 and 28 days, Bruising score at 7 and 28 days, Venous Clinical Severity Score (VCSS) at 7 and 28 days, venous duplex ultrasonography at 28 days
Measured: 7 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
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 WashingtonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Lake Washington Vascular, Sigvaris, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332838
- Sponsor's protocol ID
- COSSCA
- Status last verified
- Apr 2011
- First submitted
- 30 Mar 2011
- Last updated
- 2 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Specialized Versus Standard Compression After Saphenous Ablation
- ClinicalTrials.gov ID
- NCT01332838
- Acronym / sponsor ID
- COSSCA
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Lake Washington Vascular, Sigvaris, Inc
- Study start
- May 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 11 Apr 2011 (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 purpose of this study is to determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigvaris special compression stocking | Experimental | Device: compression stockings (Sigvaris ) |
| Standard Compression | Active comparator | Procedure: Compression stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and above
- CEAP Class C2 or C3 disease
- Incompetence of the great saphenous vein defined a reflux persisting>0.5 seconds in the upright position
- Planned endovenous ablation of the great saphenous vein
Key exclusion criteria (10 listed)
- Inability of patient or legal guardian to provide informed consent
- Previous history of DVT
- Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
- Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
- Documented allergy or intolerance to compression stockings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression stockingsstandard 30to 40 mm Hg thigh high compression stockings | Procedure or surgery | Standard Compression |
| compression stockings (Sigvaris )Specialized monoleg compression | Device | Sigvaris special compression stocking |
Primary outcome
Behavioral Recovery After Varicose Veins (BRAVV) score.
Time frame: 7 days
1 secondary outcome
Additional scoring and venous duplex ultrasonography
Time frame: 7 and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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.
Mark H Meissner, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stockings and compression stockings (Sigvaris ) in people with Varicose Veins, run by University of Washington 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda S Harrison (206-221-3341, lsh3@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Recovery After Varicose Veins (BRAVV) score. (time frame: 7 days). 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 2 May 2011.