A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedOctober 8, 2009
October 1, 2009
1 year
October 7, 2009
October 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
2 and 6 weeks
Secondary Outcomes (4)
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
Study Arms (2)
24 hours compression bandaging
ACTIVE COMPARATOR5 days compression bandaging
ACTIVE COMPARATORInterventions
Cotton wool padding will then be placed over the treated vein and secured in place by crepe bandaging. An above-knee TED stocking will be applied on top of this.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Total deep venous reflux.
- Known allergy to liquid sclerosant.
- Pregnancy or breast feeding.
- Arterial disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gloucestershire Royal Hospital NHS Trust
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Related Publications (1)
O'Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg. 2010 May;97(5):650-6. doi: 10.1002/bjs.6951.
PMID: 20306530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonothan J Earnshaw, FRCS, MD
Gloucestershire Royal Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 8, 2009
Study Start
January 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 8, 2009
Record last verified: 2009-10