NCT00991497CompletedNot Applicable
A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
Gloucestershire Hospitals NHS Foundation Trust1 site in 1 country124 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Study Overview
Brief Summary
The purpose of this study is to compare the results of foam treatment of varicose veins (foam sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Proven truncal venous incompetence (of >1 second duration) on venous duplex scanning. (Great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory thigh vein (AATV) or other major tributary).
- •Agreed preference for foam sclerotherapy treatment.
- •Signed consent form agreeing to be part of the trial.
Exclusion Criteria
- •Total deep venous reflux.
- •Known allergy to liquid sclerosant.
- •Pregnancy or breast feeding.
- •Arterial disease.
Arms & Interventions
24 hours compression bandaging
Active Comparator
Intervention: Compression bandaging (Device)
5 days compression bandaging
Active Comparator
Intervention: Compression bandaging (Device)
Outcomes
Primary Outcomes
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Time Frame: 2 and 6 weeks
Secondary Outcomes
- Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment(2 and 6 weeks)
- Change in SF-36 score from time of treatment to 6 weeks after treatment.(6 weeks)
- Target vein occlusion rate on duplex imaging at 6 weeks(6 weeks)
- Number and type of complications seen(6 weeks)
Investigators
Study Sites (1)
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