Is leg compression needed after heat treatment of varicose veins?

ISRCTN	ISRCTN18119345
DOI	https://doi.org/10.1186/ISRCTN18119345
Protocol serial number	MO2015a
Sponsor	Royal Bolton Hospital NHS Foundation Trust
Funder	Royal Bolton Hospital NHS Foundation Trust

Submission date: 10/01/2015
Registration date: 16/03/2015
Last edited: 23/10/2020

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
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

Contact information

Mr Madu Onwudike
Scientific

Vascular Surgery
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom

Phone	+44 (0)1204390105
Email	madu.onwudike@boltonft.nhs.uk

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Limb compression after radiofrequency ablation of varicose veins: a randomised controlled study
Study objectives	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(s)	NRES Committee North West – Liverpool Central, 18/03/2015, ref: 15/NW/0179
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	Successful obliteration of target vein, assessed with duplex ultrasound scan at 12–14 weeks
Key secondary outcome measure(s)	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
Completion date	01/02/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Total final enrolment	100
Key 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
Key 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
Date of first enrolment	05/02/2015
Date of final enrolment	28/01/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Bolton Hospital NHS Foundation Trust

Minerva Road
Bolton
BL4 0JR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2020	23/10/2020	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/06/2018: No publications found, verifying study status with principal investigator.
13/05/2016: Ethics approval information added.