Plain English Summary
Background and study aims
Varicose veins are a common condition, in which the veins (usually on the legs) become swollen and enlarged. It happens when the small valves inside the veins which are designed to make sure blood is travelling in the right direction (back towards the heart) stop working properly, causing blood to leak backwards and collect in the vein. Over the past decade, new minimally invasive treatments (‘key hole’ procedures) have been introduced. A common type of procedure used is ultrasound guided foam sclerotherapy. This is where special foam is injected into the veins (a process guided using ultrasound scanning) which seal the damage veins closed. This type of procedure is becoming more and more popular as they are associated with fewer complications and a quicker recovery than traditional surgery (to remove the veins). Despite advances in surgical techniques, there is still uncertainty as to the role of compression therapy (wearing tight stockings which squeeze the leg to improve circulation) in the management of varicose veins. The American Venous Forum (an American veins organisation) recommends the use of compression stockings to reduce the risk of clot (haematoma) formation, pain and swelling. The NICE Guidelines have recommended further research into the use of compression stockings as post-procedure intervention because of this lack of evidence. The aim of this study is to compare the effect of compression therapy following foam sclerotherapy.
Who can participate?
Adults with varicose veins suitable for foam sclerotherapy.
What does the study involve?
Participants in both groups undergo foam sclerotherapy of their varicose veins, before being randomly allocated to one of two groups. Those in the first group wear bandages for 24 hours and receive no compression therapy. Those in the second group are asked to wear compression stockings for 1 week following foam sclerotherapy. All participants are given a diary card to rate their pain levels every day for 10 days after their surgery. They are then received two weeks after the procedure in order to fill in questionnaires about their quality of life and undergo a physical examination to see if there is there is any skin discolouration or inflammation present. Six months after the procedure, participants attend another clinic appointment where they have an ultrasound scan to find out if the surgery has worked and fill in further questionnaires.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Charing Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2015 to December 2017
Who is funding the study?
Chemische Fabrik Kreussler & Co. GmbH (Germany)
Who is the main contact?
Mr Roshan Bootun
r.bootun@imperial.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Roshan Bootun
ORCID ID
Contact details
Vascular Research Office
Floor 4 North
Charing Cross Hospital
Imperial College London
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 20 3311 7335
r.bootun@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20419
Study information
Scientific title
A randomised controlled trial of compression therapy following foam sclerotherapy of varicose veins
Acronym
Study hypothesis
Compression therapy following foam sclerotherapy more effective than foam sclerotherapy alone.
Ethics approval
National Research Ethics Service (NRES) Committee North East - Newcastle & North Tyneside 1, 09/09/2015, ref: 15/NE/0314
Study design
Randomised; Interventional; Design type: Treatment, Device
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cardiovascular disease, Primary sub-specialty: ; UKCRC code/ Disease:
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). This will be done by using an online randomisation software (Sealed Envelope Ltd).
The compression therapy used will be Class II compression stockings. The treatment offered will be foam sclerotherapy of varicose veins using either Polidocanol or Sodium Tetradecyl Sulphate (STS) with the concentration used left to the discretion of the clinician.
Group A: Participants will be asked to wear compression stockings for 1 week following foam sclerotherapy.
Group B: Participants will be provided with bandages to wear for 24 hours only, with no further compression afterwards.
Patients in both groups will be followed-up at 2 weeks and 6 months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Pain is measured using the visual analogue scale (VAS) at baseline and daily for the first 10 days post procedure.
Secondary outcome measures
1. Quality of life is measured using EQ-5D, AVVQ and CIVIQ at baseline, 2 weeks and 6 months
2. Clinical change is assessed using the VCSS at baseline, 2 weeks and 6 months
3. Degree of phlebitis is assessed at 2 weeks and 6 months
4. Degree of skin discolouration and matting is assessed at 2 weeks and 6 months
5. Patient compliance with the intervention
6. Time taken to return to work and normal activities
7. Occlusion rates at 6 months
8. Cost effectiveness of the intervention
Overall trial start date
01/06/2015
Overall trial end date
31/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults over 18 years of age
2. Varicose veins suitable for foam sclerotherapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 350; UK Sample Size: 350
Participant exclusion criteria
1. Allergic to sclerosant
2. Current DVT
3. Arterial disease (ABPI<0.8)
4. Patients unable to wear compression stockings
5. Patient who are unwilling to participate
6. Inability or unwillingness to complete questionnaires
7. Inability to attend followup appointments
Recruitment start date
10/01/2016
Recruitment end date
31/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Charing Cross Hospital
Imperial College London
Fulham Palace Road
London
W6 8RF
United Kingdom
Funders
Funder type
Industry
Funder name
Chemische Fabrik Kreussler & Co. GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study will be presented at international meetings and will be published in peer-reviewed journals.
Intention to publish date
30/06/2021
Participant level data
Available on request
Basic results (scientific)
Publication list