Comparing endovascular laser, ultrasound-guided foam sclerotherapy, and conventional surgery for the treatment of small saphenous varicose veins

A three-arm, parallel group, randomised controlled trial of patients with small saphenous vein insufficiency treated with either endovascular laser, ultrasound-guided foam sclerotherapy, or conventional surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91735422

Enrollment

330

Registered

2010-07-08

Start date

2010-09-01

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

Small Saphenous vein varicose veins Circulatory System Varicose veins of lower extremities

Interventions

330 patients will be randomised to receive either: 1. Endovenous laser destruction of the short saphenous vein 2. Ultrasound-guided foam sclerotherapy of the short saphenous vein 3. Conventional surgi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 2. Informed approval 3. Varicose veins with symptoms, and reflux in Small Saphenous Vein defined as 0,5 seconds reflux after manual compression of the calf while standing 4. Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) classification C2-C4 5. Bilateral treatment is allowed when the same treatment is given to both legs during the same intervention

Exclusion criteria

Exclusion criteria: 1. Deep Venous Thrombosis (DVT) of the leg 2. Insufficient popliteal perforants 3. Previous varicose surgery in the popliteal area 4. Age under 18 5. Contradictions against use of Aethoxysklerol® 6. Great saphenous vein insuffienciency at the same time or surgery for Great Saphenous vein insufficiency < 3 months previously 7. History or foot-pulse indicating arterial insufficiency or/and ankle/arm index <0.9 8. Convoluted or disrupted Parva, that will make it inappropriate for the treatments 9. Other anatomical relations that will make surgery difficult 10. Pregnant or have given birth < 3 months previously

Design outcomes

Primary

Measure	Time frame
Amended as of 12/11/2010 to following: 1. Efficacy 2. Recurrent varicose veins Initial information at time of registration: 1. Interruption of sensitivity and motor skills 2. Reflux equivalent to the inlet of Parva, more than 1,5cm from the inlet and distally equivalent to the treated part of Parva 3. Reflux equivalent to new vessels/perforants in the fossa poplitea 4. New varicose veins 5. Return to normal activities 6. Return to work 7. Use of pain tablets 8. Pain score (analogue scale 0-10), daily for the first 10 days 9. Additional venous treatments on the treated leg	—

Measure

Time frame

Amended as of 12/11/2010 to following: 1. Efficacy 2. Recurrent varicose veins Initial information at time of registration: 1. Interruption of sensitivity and motor skills 2. Reflux equivalent to the inlet of Parva, more than 1,5cm from the inlet and distally equivalent to the treated part of Parva 3. Reflux equivalent to new vessels/perforants in the fossa poplitea 4. New varicose veins 5. Return to normal activities 6. Return to work 7. Use of pain tablets 8. Pain score (analogue scale 0-10), daily for the first 10 days 9. Additional venous treatments on the treated leg

—

Secondary

Measure	Time frame
Amended as of 12/11/2010 to following: 1. Interruption of sensitivity and motor skills 2. Reflux equivalent to the inlet of Parva, more than 1.5 cm from the inlet and distally equivalent to the treated part of Parva 3. Reflux equivalent to new vessels/perforants in the fossa poplitea 4. New varicose veins 5. Return to normal activities 6. Return to work 7. Use of pain tablets 8. Pain score (analogue scale 0 - 10), daily for the first 10 days 9. Additional venous treatments on the treated leg Initial information at time of registration: 1. Intervention time from "skin to skin" 2. Number of phlebectomies 3. Small saphenous vein diameter 5 cm distal from the saphenopopliteal inlet 4. Aberdeen varicose veins symptoms severity score (AVVSS) 5. SF - 36 quality of life questionnaire 6. Venous severity score 7. Venous procedures on the treated leg	—

Measure

Time frame

Amended as of 12/11/2010 to following: 1. Interruption of sensitivity and motor skills 2. Reflux equivalent to the inlet of Parva, more than 1.5 cm from the inlet and distally equivalent to the treated part of Parva 3. Reflux equivalent to new vessels/perforants in the fossa poplitea 4. New varicose veins 5. Return to normal activities 6. Return to work 7. Use of pain tablets 8. Pain score (analogue scale 0 - 10), daily for the first 10 days 9. Additional venous treatments on the treated leg Initial information at time of registration: 1. Intervention time from "skin to skin" 2. Number of phlebectomies 3. Small saphenous vein diameter 5 cm distal from the saphenopopliteal inlet 4. Aberdeen varicose veins symptoms severity score (AVVSS) 5. SF - 36 quality of life questionnaire 6. Venous severity score 7. Venous procedures on the treated leg

—

Countries

Denmark, Sweden

Outcome results

None listed

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