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NCT00991497 Clinical Trial

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

Varicose Veins Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00991497
Other study ID # 06/Q2005/128
Secondary ID
Status Completed
Phase N/A
First received October 7, 2009
Last updated October 7, 2009
Start date January 2007
Est. completion date January 2008

Study information
Verified date October 2009
Source Gloucestershire Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Compression bandaging
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.

Locations
Country Name City State
United Kingdom Gloucestershire Royal Hospital NHS Trust Gloucester Gloucestershire

Sponsors (1)
Lead Sponsor Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment 2 and 6 weeks No
Secondary Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment 2 and 6 weeks No
Secondary Change in SF-36 score from time of treatment to 6 weeks after treatment. 6 weeks No
Secondary Target vein occlusion rate on duplex imaging at 6 weeks 6 weeks No
Secondary Number and type of complications seen 6 weeks Yes
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