A single-centre study looking at the effect of compression therapy in patients having foam sclerosant injection for varicose veins
| ISRCTN | ISRCTN17719156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17719156 |
| ClinicalTrials.gov number | NCT02655406 |
| Secondary identifying numbers | 20419 |
- Submission date
- 11/04/2016
- Registration date
- 20/04/2016
- Last edited
- 07/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Vascular Research Office
Floor 4 North
Charing Cross Hospital
Imperial College London
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 20 3311 7335 |
|---|---|
| r.bootun@imperial.ac.uk |
Scientific
Four North
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
 ORCID ID |
0000-0003-2057-6755 |
|---|---|
| Phone | None provided |
| a.belramman17@imperial.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial of compression therapy following foam sclerotherapy of varicose veins |
| Study objectives | Compression therapy following foam sclerotherapy more effective than foam sclerotherapy alone. |
| Ethics approval(s) | National Research Ethics Service (NRES) Committee North East - Newcastle & North Tyneside 1, 09/09/2015, ref: 15/NE/0314 |
| Health condition(s) or problem(s) studied | Varicose veins |
| 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 |
| 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 study start date | 01/06/2015 |
| Completion date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350; UK Sample Size: 350 |
| Total final enrolment | 139 |
| Key inclusion criteria | 1. Adults over 18 years of age 2. Varicose veins suitable for foam sclerotherapy |
| Key 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 |
| Date of first enrolment | 10/01/2016 |
| Date of final enrolment | 31/01/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fulham Palace Road
London
W6 8RF
United Kingdom
Sponsor information
Hospital/treatment centre
-
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study will be presented at international meetings and will be published in peer-reviewed journals. |
| IPD sharing plan | Anonymised data is available on request by researchers after the publication of the manuscript from Prof. Alun Davies (a.h.davies@imperial.ac.uk) or Mr Tristan Lane (tristan.lane@imperial.ac.uk). It will be uploaded to a secure data repository for ease of access. Consent for anonymised analysis of data and consent for publication has been ethically approved and prospectively sought from participants. This data will be stored for 10 years in line with Imperial College London guidelines and will be available from that time. All data should be referenced and cited appropriately. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.1 | 04/05/2017 | 18/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | version 23 | 06/11/2023 | 06/11/2023 | No | No |
| Results article | 01/03/2024 | 07/05/2025 | Yes | No |
Additional files
Editorial Notes
07/05/2025: Publication reference added.
06/11/2023: The following changes have been made:
1. Basic results added.
2. Scientific contact added.
05/06/2023: The intention to publish date was changed from 30/06/2023 to 31/12/2023.
18/10/2022: Protocol file uploaded.
13/06/2022: The intention to publish date was changed from 30/06/2022 to 30/06/2023.
02/06/2021: The intention to publish date was changed from 30/06/2021 to 30/06/2022.
17/02/2021: IPD sharing statement added.
28/01/2021: Total final enrolment and ClinicalTrials.gov number added.
02/04/2019: The condition has been changed from "Specialty: Cardiovascular disease, Primary sub-specialty: ; UKCRC code/ Disease:" to "Varicose veins" following a request from the NIHR.
05/10/2018: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2019 to 31/01/2020.
2. The overall trial end date has been changed from 01/12/2017 to 31/01/2021.
3. The intention to publish date has been changed from 31/03/2018 to 30/06/2021.
4. The total target enrolment has been changed from 350 to 180.
04/10/2018: The recruitment end date has been changed from 10/01/2017 to 31/01/2019.
