A 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 Trust

Status: Completed

Conditions: Varicose Veins

Treatments: Device: Compression bandaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00991497

06/Q2005/128

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

24 hours compression bandaging

Active Comparator group

Treatment:

Device: Compression bandaging

5 days compression bandaging

Active Comparator group

Treatment:

Device: Compression bandaging