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

ISRCTN	ISRCTN03080206
DOI	https://doi.org/10.1186/ISRCTN03080206
Protocol serial number	08/H0710/78
Sponsor	Ealing Hospital NHS Trust (UK)
Funders	Ealing Hospital NHS Trust (UK) - Research and Development Department, STD Pharmaceuticals Ltd (UK)

Submission date: 21/01/2010
Registration date: 04/02/2010
Last edited: 04/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Varicose veins are swollen and enlarged veins that usually occur on the legs. The aim of this study is to compare two treatments for varicose veins: endovenous laser therapy and ultrasound-guided foam sclerotherapy. Endovenous laser therapy involves having a tiny laser inserted into the vein, which delivers bursts of energy that heat up the vein and seal it closed. Ultrasound-guided foam sclerotherapy involves injecting special foam into the vein, which seals it closed.

Who can participate?
Patients aged 18 or over with varicose veins

What does the study involve?
Participants are randomly allocated to be treated with either endovenous laser therapy or ultrasound-guided foam sclerotherapy. Participants are followed up for 5 years to assess their recovery, quality of life, pain and the costs of treatment.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Ealing Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2009 to May 2016

Who is funding the study?
1. Ealing Hospital NHS Trust (UK)
2. STD Pharmaceuticals Ltd (UK)

Who is the main contact?
George Geroulakos
g.geroulakos@imperial.ac.uk

Contact information

Mr George Geroulakos
Scientific

Consultant Vascular Surgeon and Senior Lecturer
Ealing Hospital
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom

Email	g.geroulakos@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins
Study objectives	Patient recovery, quality of life, post-procedural pain and the direct medical costs of treatment are significantly different between endovenous laser therapy (EVLT) and ultrasound guided foam sclerotherapy (UGFS).
Ethics approval(s)	Ealing and West London Research Ethics Committee, 17/03/2009
Health condition(s) or problem(s) studied	Chronic venous insufficiency
Intervention	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) to two further optional sessions, 6 weeks apart (3 months). Total duration of follow-up is 3 months after the last treatment session. Updated 17/06/2014: Follow-up has been extended to 5 years after the last treatment session.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/05/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	31/05/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Ealing Hospital

Middlesex
UB1 3HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Results article	results	01/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/03/2016: Plain English summary added.

On 17/06/2014 the overall trial end date was changed from 31/03/2011 to 31/05/2016.