Varicose VeinsPhase 4NCT03416413
Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy
A Phase 4 study testing Ambulatory phlebectomy and Foam sclerotherapy in people with Varicose Veins, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein. 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?
- Ambulatory phlebectomy and Foam sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 30 Jun 2025
- Phase
- Phase 4
- 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
- Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
- Varicose vein tributary requiring treatment
Who cannot join
- Current DVT
- Recurrent varicose veins
- Arterial disease (ABPI<0.8)
- Vein diameter < 3mm
- Preference for one of the treatment options
- Patient who are unwilling to participate
Show all 9Show fewer
- Inability or unwillingness to complete questionnaires
- Inability to attend follow-up appointments
- Patient currently included in a study of varicose vein treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital, Imperial College London
London, W6 8RF
Amjad Belramman, +442033117335, a.belramman17@imperial.ac.uk
Roshan Bootun, +442033117335, r.bootun@imperial.ac.uk
About this study
Official title: Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.
The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
- Conditions
- Varicose Veins
- Being tested
- Ambulatory phlebectomy, Foam sclerotherapy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory phlebectomyProcedure or surgery
Minor surgery to remove varicose vein tributaries
Foam sclerotherapyDrug
Injection of foam sclerosant into varicose vein tributaries
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Phlebectomy | Active comparator | Ambulatory phlebectomy of varicose vein tributaries Receives: Procedure: Ambulatory phlebectomy |
| Foam Sclerotherapy | Active comparator | Injection of foam sclerosant into varicose vein tributaries Receives: Drug: Foam sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intervention rate
Re-intervention on varicose vein tributaries during study period
Measured: 12 months
Secondary outcomes (8)
Generic quality of life score
Quality of life score using the EuroQol's EQ-5D [0=worse quality of life; 1=best quality of life]
Measured: 12 months
Disease-specific quality of life score
Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) [0=worse quality of life; 100= best quality of life]
Measured: 12 months
Disease specific quality of life score
Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) [0=worse quality of life; 100=best quality of life]
Measured: 12 months
Clinical score
Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease]
Measured: 12 months
Clinical score
Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification [0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer]
Measured: 12 months
Pain score over the first 10 days
Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
Measured: 2 weeks
Degree of bruising at 2 weeks
Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment)
Measured: 2 weeks
Time to return to normal activities
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Feb 2018
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416413
- Sponsor's protocol ID
- 17/WS/0192
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2018
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belramman A, Bootun R, Lane TRA, Davies AH. Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial. Trials. 2019 Jul 3;20(1):392. doi: 10.1186/s13063-019-3398-0.
PubMed 31269978
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
- ClinicalTrials.gov ID
- NCT03416413
- Acronym / sponsor ID
- 17/WS/0192
- Conditions
- Varicose Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Jan 2018 (actual)
- 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 comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.
The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Phlebectomy | Active comparator | Procedure: Ambulatory phlebectomyAmbulatory phlebectomy of varicose vein tributaries |
| Foam Sclerotherapy | Active comparator | Drug: Foam sclerotherapyInjection of foam sclerosant into varicose vein tributaries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years of age
- Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
- Varicose vein tributary requiring treatment
Key exclusion criteria (9 listed)
- Current DVT
- Recurrent varicose veins
- Arterial disease (ABPI<0.8)
- Vein diameter < 3mm
- Preference for one of the treatment options
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 |
|---|---|---|
| Ambulatory phlebectomyMinor surgery to remove varicose vein tributaries | Procedure or surgery | Ambulatory Phlebectomy |
| Foam sclerotherapyInjection of foam sclerosant into varicose vein tributaries | Drug | Foam Sclerotherapy |
Primary outcome
Re-intervention rate
Time frame: 12 months
Re-intervention on varicose vein tributaries during study period
8 secondary outcomes
Generic quality of life score
Time frame: 12 months
Disease-specific quality of life score
Time frame: 12 months
Disease specific quality of life score
Time frame: 12 months
Clinical score
Time frame: 12 months
Clinical score
Time frame: 12 months
Pain score over the first 10 days
Time frame: 2 weeks
Degree of bruising at 2 weeks
Time frame: 2 weeks
Time to return to normal activities
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 31269978Belramman A, Bootun R, Lane TRA, Davies AH. Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial. Trials. 2019 Jul 3;20(1):392. doi: 10.1186/s13063-019-3398-0.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ambulatory phlebectomy and Foam sclerotherapy 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amjad Belramman (02033117335, a.belramman17@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intervention rate (time frame: 12 months). 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 NCT03416413, 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 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.