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Clinical Trials/NCT00991497
NCT00991497
Completed
Not 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 enrollmentJanuary 2007
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ConditionsVaricose Veins

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Varicose Veins
Sponsor
Gloucestershire Hospitals NHS Foundation Trust
Enrollment
124
Locations
1
Primary Endpoint
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
January 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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.

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 SF-36 score from time of treatment to 6 weeks after treatment.(6 weeks)
  • Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment(2 and 6 weeks)
  • Target vein occlusion rate on duplex imaging at 6 weeks(6 weeks)
  • Number and type of complications seen(6 weeks)

Study Sites (1)

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