Endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins

Randomised controlled trial of endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03080206

Enrollment

100

Registered

2010-02-04

Start date

2009-04-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Chronic venous insufficiency Circulatory System Other disorders of veins

Interventions

Group 1: UGFS to the long saphenous vein Group 2: EVLT to the long saphenous vein and concurrent local anaesthetic phlebectomies Total duration of treatment ranges from the primary procedure (1 day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged 18 years or over, either sex) with symptomatic primary varicose veins in the long saphenous distribution and reflux greater than 1 second on duplex scanning 2. Suitability for both techniques, foam and laser

Exclusion criteria

Exclusion criteria: 1. Saphenopopliteal junction incompetence 2. Previous surgery for varicose veins 3. Previous sclerotherapy for varicose veins 4. Deep vein thrombosis, previous or current 5. Significant arterial disease (Ankle Brachial Pressure Index [ABPI] less than 0.8) 6. Active malignancy 7. Coagulopathy 8. Pregnancy 9. Known allergies to local anaesthetics or sclerosants

Design outcomes

Secondary

Measure	Time frame
1. Direct medical costs 2. Number of treatment sessions 3. Incidence of side-effects and complications 4. Effectiveness of treatment using duplex and air plethysmography 5. Post-procedural pain scores using a visual analogue scale 6. Change in clinical severity using the venous clinical severity scoring system All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.	—

Measure

Time frame

1. Direct medical costs 2. Number of treatment sessions 3. Incidence of side-effects and complications 4. Effectiveness of treatment using duplex and air plethysmography 5. Post-procedural pain scores using a visual analogue scale 6. Change in clinical severity using the venous clinical severity scoring system All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.

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Primary

Measure	Time frame
1. Return to normal activities 2. Quality of life using the Aberdeen Varicose Vein Questionnaire All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.	—

Measure

Time frame

1. Return to normal activities 2. Quality of life using the Aberdeen Varicose Vein Questionnaire All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026