Varicose VeinsCONFETTINCT02655406
COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins
A study testing Class 2 compression stockings in people with Varicose Veins, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Class 2 compression stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Varicose veins suitable for foam sclerotherapy
Who cannot join
- Allergic to sclerosant
- Current DVT
- Arterial disease (ABPI<0.8)
- Patients unable to wear compression stockings
- Patients who are unwilling to participate
- Inability or unwillingness to complete questionnaires
- Inability to attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Read the detailed description
This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.
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.
Patients randomised to group A will be asked to wear compression stockings for 1 week.
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards.
At baseline, patients will be asked to fill validated quality of life questionnaires (EQ-5D, AVVQ and CIVIQ) and will have their clinical scores assessed using a validated scoring system (CEAP and VCSS). On discharge after their varicose vein intervention, they will then be provided with a diary to record their post-procedural pain every day for 10 days using a validated visual analogue scale (VAS) as well as to record when they return to their normal activities and are back to work. They will also be asked to attend a follow-up in 2 weeks and at 6 months.
Patients' GP will also be sent a letter to inform them of their patient's participation in the study.
Follow-up
Patients will be followed up in the outpatient clinic at 2 weeks and 6 months.
Follow-up at 2 Weeks
At the 2 weeks' follow-up, the diary containing details of the pain scores and how soon patients were able to return to normal activities/work will be collected. In addition, patients will be asked about any phlebitis they have had in the two weeks after their procedure and how compliant they have been with the compression. They will be examined and the Venous Clinical Severity Score (VCSS) will be recorded. They will also be asked to fill in the EQ-5D, AVVQ and CIVIQ scores.
Follow-up at 6 Months
At the 6 months follow-up, patients will be examined and their VCSS will be recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. They will have a venous Duplex scan to determine occlusion of the treated vein.
Sample Size and Study Duration
We estimated the sample size needed to observe a difference of at least 10mm in the VAS score, with a standard deviation of 20mm. With power at 80% and 5% significance equivalence, we would need to recruit 128 patients (64 per group) to show a difference.
Previous studies looking at compression stockings have shown drop out rates close to 37% at 3 months10. Therefore, if we estimate a drop out rate of about 40% by 6 months, we would need to recruit at least 180 patients. If we recruit at least 2 patients per week, this will be approximately a total of 208 patients that could potentially be randomised over the course of two years.
With 6 months follow-up, therefore, the study will be running for 24 months with a target recruitment of 180 patients.
- Conditions
- Varicose Veins
- Being tested
- Class 2 compression stockings
- Keywords
- Foam sclerotherapy, Compression
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class 2 compression stockingsOther
| Study group | Role | What they receive |
|---|---|---|
| Compression stockings | Active comparator | Patients randomised to group A will be asked to wear compression stockings for 1 week Receives: Other: Class 2 compression stockings |
| No compression | No intervention | Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's pain score post-procedure using a visual analogue scale (VAS)
Pain score
Measured: 10 days
Secondary outcomes (6)
Aberdeen Varicose Vein Questionnaire (AVVQ) score
Disease-specific quality of life score
Measured: 6 months
Chronic venous insufficiency (CIVIQ) score
Disease-specific quality of life score
Measured: 6 months
EuroQol's EQ-5D
Generic quality of life score
Measured: 6 months
Venous clinical severity score (VCSS)
Clinical
Measured: 6 months
Occlusion rate
Occlusion rates will be assessed based on a pre-agreed scale
Measured: 6 months
Degree of phlebitis
Extent of phlebitis will be recorded using a scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2020
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roshan Bootun, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655406
- Sponsor's protocol ID
- 15/NE/0314
- Acronym
- CONFETTI
- Status last verified
- Aug 2022
- First submitted
- 12 Jan 2016
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belramman A, Bootun R, Lane TRA, Davies AH. COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI). J Vasc Surg Venous Lymphat Disord. 2024 Mar;12(2):101729. doi: 10.1016/j.jvsv.2023.101729. Epub 2023 Dec 9.
PubMed 38081513
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
- ClinicalTrials.gov ID
- NCT02655406
- Acronym / sponsor ID
- CONFETTI / 15/NE/0314
- Conditions
- Varicose Veins
- Keywords
- Foam sclerotherapy, Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Detailed description
This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.
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.
Patients randomised to group A will be asked to wear compression stockings for 1 week.
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards.
At baseline, patients will be asked to fill validated quality of life questionnaires (EQ-5D, AVVQ and CIVIQ) and will have their clinical scores assessed using a validated scoring system (CEAP and VCSS). On discharge after their varicose vein intervention, they will then be provided with a diary to record their post-procedural pain every day for 10 days using a validated visual analogue scale (VAS) as well as to record when they return to their normal activities and are back to work. They will also be asked to attend a follow-up in 2 weeks and at 6 months.
Patients' GP will also be sent a letter to inform them of their patient's participation in the study.
Follow-up
Patients will be followed up in the outpatient clinic at 2 weeks and 6 months.
Follow-up at 2 Weeks
At the 2 weeks' follow-up, the diary containing details of the pain scores and how soon patients were able to return to normal activities/work will be collected. In addition, patients will be asked about any phlebitis they have had in the two weeks after their procedure and how compliant they have been with the compression. They will be examined and the Venous Clinical Severity Score (VCSS) will be recorded. They will also be asked to fill in the EQ-5D, AVVQ and CIVIQ scores.
Follow-up at 6 Months
At the 6 months follow-up, patients will be examined and their VCSS will be recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. They will have a venous Duplex scan to determine occlusion of the treated vein.
Sample Size and Study Duration
We estimated the sample size needed to observe a difference of at least 10mm in the VAS score, with a standard deviation of 20mm. With power at 80% and 5% significance equivalence, we would need to recruit 128 patients (64 per group) to show a difference.
Previous studies looking at compression stockings have shown drop out rates close to 37% at 3 months10. Therefore, if we estimate a drop out rate of about 40% by 6 months, we would need to recruit at least 180 patients. If we recruit at least 2 patients per week, this will be approximately a total of 208 patients that could potentially be randomised over the course of two years.
With 6 months follow-up, therefore, the study will be running for 24 months with a target recruitment of 180 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression stockings | Active comparator | Other: Class 2 compression stockingsPatients randomised to group A will be asked to wear compression stockings for 1 week |
| No compression | No intervention | –Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over 18 years of age
- Varicose veins suitable for foam sclerotherapy
Key exclusion criteria (7 listed)
- Allergic to sclerosant
- Current DVT
- Arterial disease (ABPI<0.8)
- Patients unable to wear compression stockings
- Patients who are unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class 2 compression stockings | Other | Compression stockings |
Primary outcome
Patient's pain score post-procedure using a visual analogue scale (VAS)
Time frame: 10 days
Pain score
6 secondary outcomes
Aberdeen Varicose Vein Questionnaire (AVVQ) score
Time frame: 6 months
Chronic venous insufficiency (CIVIQ) score
Time frame: 6 months
EuroQol's EQ-5D
Time frame: 6 months
Venous clinical severity score (VCSS)
Time frame: 6 months
Occlusion rate
Time frame: 6 months
Degree of phlebitis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 38081513Belramman A, Bootun R, Lane TRA, Davies AH. COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI). J Vasc Surg Venous Lymphat Disord. 2024 Mar;12(2):101729. doi: 10.1016/j.jvsv.2023.101729. Epub 2023 Dec 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan Bootun principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class 2 compression stockings in people with Varicose Veins, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's pain score post-procedure using a visual analogue scale (VAS) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.