Condition category
Circulatory System
Date applied
21/01/2010
Date assigned
04/02/2010
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr George Geroulakos

ORCID ID

Contact details

Consultant Vascular Surgeon and Senior Lecturer
Ealing Hospital
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom
-
g.geroulakos@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/H0710/78

Study information

Scientific title

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

Acronym

Study hypothesis

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

Ealing and West London Research Ethics Committee, 17/03/2009

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/04/2009

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/04/2009

Recruitment end date

31/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ealing Hospital
Middlesex
UB1 3HW
United Kingdom

Sponsor information

Organisation

Ealing Hospital NHS Trust (UK)

Sponsor details

Research and Development Office
Pasteur Suite
8th Floor
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom
-
gay.bineham@eht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.ealinghospital.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Ealing Hospital NHS Trust (UK) - Research and Development Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

STD Pharmaceuticals Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22386383
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23822942

Publication citations

  1. Results

    Lattimer CR, Azzam M, Kalodiki E, Shawish E, Trueman P, Geroulakos G, Cost and effectiveness of laser with phlebectomies compared with foam sclerotherapy in superficial venous insufficiency. Early results of a randomised controlled trial., Eur J Vasc Endovasc Surg, 2012, 43, 5, 594-600, doi: 10.1016/j.ejvs.2012.01.032.

  2. Results

    Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G, Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy., Int Angiol, 2013, 32, 4, 394-403.

Additional files

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.