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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00991497
Enrollment
124
Registered
2009-10-08
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2009-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

varicose veins, foam sclerotherapy, compression bandaging, duration

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.

Interventions

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.

Sponsors

Gloucestershire Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment2 and 6 weeks

Secondary

MeasureTime frame
Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment2 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 weeks6 weeks
Number and type of complications seen6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026