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Completed

NCT Number: NCT00991497

A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gloucestershire Royal Hospital NHS Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compression bandaging

Device

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.

Primary outcomes

  1. 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

  1. Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment

    Time frame: 2 and 6 weeks

  2. Change in SF-36 score from time of treatment to 6 weeks after treatment.

    Time frame: 6 weeks

  3. Target vein occlusion rate on duplex imaging at 6 weeks

    Time frame: 6 weeks

  4. Number and type of complications seen

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Gloucestershire Hospitals NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 8, 2009
Registry last updated
Oct 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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