Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Nadarajah Theivacumar


Contact details

Leeds Vascular Institute
Leeds General Infirmary
Great George Street
United Kingdom
+44 (0)7940 774550

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Leeds EVLA technique trial

Study hypothesis

Modified techniques reduces requirement of delayed foam sclerotherapy and provides better clinical outcome.

Ethics approval

Leeds (West) research ethics committee, at Leeds General Infirmary on 21/09/2005 (ref: 05/Q1205/187)

Study design

Randomised controlled trial (not blinded)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Varicose veins


Two modified techniques are compared with standard EVLA technique:
Group A: the standard practice of EVLA (laser ablation of above-knee Great Saphenous Vein [GSV]) considered as control
Group B: modification 1 - where GSV was ablated (EVLA) both above and below knee
Group C: modification 2 - where above knee GSV was ablated by EVLA and below knee GSV was chemically ablated using foam sclerotherapy at the same time

Group 1 - standard EVLA alone:
This uses an 810 nm bare-tipped, pulsed laser (Diomed Inc.) at a power of 12 watts. The standard technique for EVLA will be used employing a laser density of 5 pulse/cm. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was used as required at the follow up clinic visit/s.

Group 2 - standard EVLA and on table foam sclerotherapy:
The same EVLA technique as for group 1 was used except that the GSV was cannulated below-knee (mid-calf) and a 70 cm sheath inserted. The GSV was ablated (EVLA) to the level of the knee joint following which 5 ml 1% STD (2 ml 1% STD, 3 ml air) will be injected into the below knee GSV via the sheath as it was withdrawn. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also be used as required at the follow up clinic visit/s.

Group 3 - above and below-knee EVLA:
The GSV was canulated below-knee (mid-calf) and the whole length of the GSV ablated using the standard EVLA technique. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also used as required at the follow up clinic visit/s.

Following this primary treatment patients were followed up at 1, 6, and 12 weeks and following data were obtained at each visit:
1. At 1 week:
1.1. Daily Visual Analogue Score for pain
1.2. Analgesia diary
1.3. Time to normal activity - time to return to work
1.4. Assessment of post-treatment complications
1.5. Duplex assessment of GSV and deep veins for evidence of Deep Vein Thrombosis (DVT)
2. At 6 weeks:
2.1. Outstanding data from week 1
2.2. Aberdeen Vein Questionnaire (disease-specific quality of life measure)***
2.3. Late complications
2.4. Time of return to work if greater than 1 week
2.5. Injection sclerotherapy as required in all patients
2.6. Duplex assessment of GSV
3. At 12 weeks:
3.1. Any outstanding data (as above)
3.2. Duplex Ultrasound Assessment
3.3. Aberdeen Vein Questionnaire (disease-specific quality of life measure)***
3.4. EuroQol questionnaire
3.5. Patient satisfaction
3.6. Number of sessions of injection Sclerotherapy as required***
3.7. Duplex assessment

*** = Primary endpoint measurements

Intervention type



Not Specified

Drug names

Primary outcome measures

Sclerotherapy requirement at follow up: disease specific quality of life improvement measured by Aberdeen varicose vein severity score.

Secondary outcome measures

1. Post-procedure pain: patient analgesia diary
2. Cosmesis: as scored by the patient
3. Complication rates: wound infection, haematoma, nerve injury, DVT
4. Patient satisfaction

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Patients with primary varicose veins in the leg due to isolated incompetent sapheno-femoral junction and great saphenous vein reflux both above and below knee segments.

Participant type


Age group

Not Specified


Not Specified

Target number of participants

69 participants

Participant exclusion criteria

1. Recurrent varicose veins
2. Patients with reflux in other axial veins
3. Patients with varicose veins only in thigh
4. Patients who has no reflux in below-knee segment of great saphenous vein

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Leeds Vascular Institute
United Kingdom

Sponsor information


Leeds General Infirmary (UK)

Sponsor details

c/o Mr M.J. Gough
Great George Street
United Kingdom
+44 (0)113 392 2823

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

Leeds Vascular Institute (UK) - Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in

Publication citations

  1. Results

    Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ, Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial., J. Vasc. Surg., 2008, 48, 1, 173-178, doi: 10.1016/j.jvs.2008.01.062.

Additional files

Editorial Notes