Condition category
Circulatory System
Date applied
28/06/2010
Date assigned
08/07/2010
Last edited
24/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Small saphenous varicose veins are swollen and enlarged veins – usually blue or dark purple – that are found on the legs. The aim of this study is to compare three treatments for small saphenous varicose veins: endovenous laser treatment, ultrasound-guided foam sclerotherapy, and conventional surgery. Endovenous laser treatment involves having a catheter inserted into the affected vein; a tiny laser is passed through the catheter that delivers short bursts of energy to heat up the vein and seal it closed. Ultrasound-guided foam sclerotherapy involves injecting special foam into the affected vein, which scars the vein and seals it closed.

Who can participate?
Patients aged 18-75 with varicose veins

What does the study involve?
Participants are randomly allocated to be treated with either endovenous laser treatment, ultrasound-guided foam sclerotherapy, or conventional surgical removal of the short saphenous vein. Participants are followed up after 3 days, 1 month, 1 year, 3 years, and 5 years to assess treatment effectiveness and recurrence of the varicose veins.

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

Where is the study run from?
Åreknudeklinikken (Denmark)

When is the study starting and how long is it expected to run for?
September 2010 to September 2020

Who is funding the study?
Foundation of the National Health Security System (Fonden for faglig udvikling af speciallægepraksis) (Denmark)

Who is the main contact?
Dr Lars H. Rasmussen
lhr@varix.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lars H. Rasmussen

ORCID ID

Contact details

Nordre Kystagervej 28
Hviovre
2650
Denmark
+45 40824418
lhr@varix.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

26141788A

Study information

Scientific title

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

Acronym

Study hypothesis

Successful treatment of small saphenous varicose veins using laser, foam or surgery is equally possible, and will give a successful removal of insufficiency in 90% of patients treated.

Ethics approval

The local Danish ethics committee approved in April 2010

Study design

Multicentre three-arm randomised controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Small Saphenous vein varicose veins

Intervention

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 surgical removal of the short saphenous vein

Follow up after 3 days, 1 month, 1 year, 3 years, and 5 years thereafter.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/09/2010

Overall trial end date

01/09/2020

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant 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

Recruitment start date

01/09/2010

Recruitment end date

01/09/2020

Locations

Countries of recruitment

Denmark, Sweden

Trial participating centre

Nordre Kystagervej 28
Hviovre
2650
Denmark

Sponsor information

Organisation

Åreknudeklinikken (Denmark)

Sponsor details

Eskadronsvej 4A
Naestved
4700
Denmark
-
lhr@varix.dk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Foundation of the National Health Security System (Fonden for faglig udvikling af speciallægepraksis) (Denmark)

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

Publication citations

Additional files

Editorial Notes

24/06/2016: Plain English summary added.