Condition category
Circulatory System
Date applied
10/01/2015
Date assigned
16/03/2015
Last edited
13/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Leg compression after heat treatment of swollen or enlarged veins is used to reduce the procedure-related side-effects. There is not enough evidence to lend support to the use of leg compression. The aim of this study is to investigate whether leg compression is needed after heat treatment of varicose veins.

Who can participate?
Individuals with enlarged or swollen veins referred to clinics at Royal Bolton Hospital (UK)

What does the study involve?
Patients will be randomly allocated to heat treatment of their veins followed by leg compression or no leg compression.

What are the possible benefits and risks of participating?
Benefits are a reduction in the occurrence of blood clots in veins, pain and inflammation. Risks might be discomfort associated with limb compression and movement restriction.

Where is the study run from?
Royal Bolton Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
From February 2015 to February 2016

Who is funding the study?
Royal Bolton Hospital NHS Foundation Trust (UK)

Who is the main contact?
Mr Madu Onwudike
madu.onwudike@boltonft.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Madu Onwudike

ORCID ID

Contact details

Vascular Surgery
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
+441204390105
madu.onwudike@boltonft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MO2015a

Study information

Scientific title

Limb compression after radiofrequency ablation of varicose veins: a randomised controlled study

Acronym

Study hypothesis

The outcome in patients who have not worn compression hosiery after radiofrequency ablation of varicose veins is not inferior to those who have worn the hosiery in the post-treatment period.

Ethics approval

NRES Committee North West – Liverpool Central, 18/03/2015, REC Ref: 15/NW/0179

Study design

Single-centre randomised controlled study

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 below to request a patient information sheet.

Condition

Varicose veins

Intervention

1. Compression after radiofrequency ablation of lower limb varicose veins
2. No compression after radiofrequency ablation of lower limb varicose veins

Intervention type

Device

Phase

Drug names

Primary outcome measures

Successful obliteration of target vein, assessed with duplex ultrasound scan at 12–14 weeks

Secondary outcome measures

1. Quality of life, assessed with the Aberdeen Varicose Vein Severity Score and the Venous Clinical Severity Score at baseline (on the day of surgery) and at 12 weeks
2. Complications: recorded during patients' follow-up or emergency admissions, including any problems specifically related to stockings from the first post-operative day to 12 weeks
3. Patient's satisfaction, assessed with a patient satisfaction questionnaire
4. Pain, measured with the Visual Analogue Scale questionnaire; completed by the patient during the first post-operative week and collected at the 2 week review
5. Return to normal activities: information obtained by direct questioning at the 2 week interview and reconfirmed at 12 weeks

Overall trial start date

01/02/2015

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18–90 years old
2. C2 to C6 disease and referred to clinics at Royal Bolton Hospital (UK)
3. Veins anatomically suitable for endothermal ablation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Unable to provide informed consent or comply with the study protocol
2. Varicose veins unsuitable for radiofrequency ablation (e.g., very tortuous veins)
3. Pregnancy
4. Lycra allergy
5. Patients who have opted for an alternative method of treatment

Recruitment start date

05/02/2015

Recruitment end date

28/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Bolton Hospital NHS Foundation Trust
Minerva Road Bolton BL4 0JR
Bolton
BL4 0JR
United Kingdom

Sponsor information

Organisation

Royal Bolton Hospital NHS Foundation Trust

Sponsor details

Minerva Road
Fanworth
Bolton
BL4 0JR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Bolton Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Oral presentation at the European Venous Forum and American Venous Forum; original article published in one of the major vascular journals

Intention to publish date

30/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/05/2016: Ethics approval information added.