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RecruitingNCT03416413Updated Jul 5, 2024

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

A Phase 4 interventional study of Ambulatory phlebectomy and Foam sclerotherapy in Varicose Veins, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Imperial College London · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2018; still recruiting 8 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Varicose Veins by Imperial College London — 2 open to participants now, 2 under way, none of them phase 3. Varicose Veins · Imperial College London.

Started
2018
the only one that year
Phase 4
2 of 10
2 open now
Registered
6th of 10
by date

Among the 10 studies in Varicose Veins by Imperial College London, this one is the only one that started in 2018, is one of 2 in phase 4, and was the 6th registered.

Varicose Veins

226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.

Browse Varicose Veins studies →

Open to participants now

2 of the 10 studies in Varicose Veins by Imperial College London are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 22 Varicose Veins studies recruiting now, 12 (55%) set no upper age limit and 4 (18%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.

03

Conditions studied

  • Varicose Veins

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults over 18 years of age
  • Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
  • Varicose vein tributary requiring treatment

Exclusion criteria

Exclusion Criteria:

  • 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
  • Inability or unwillingness to complete questionnaires
  • Inability to attend follow-up appointments
  • Patient currently included in a study of varicose vein treatment
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Ambulatory Phlebectomy

    Ambulatory phlebectomy of varicose vein tributaries

    Procedure: Ambulatory phlebectomy

  • Active comparator
    Foam Sclerotherapy

    Injection of foam sclerosant into varicose vein tributaries

    Drug: Foam sclerotherapy

Interventions

  • ProcedureAmbulatory phlebectomy

    Minor surgery to remove varicose vein tributaries

  • DrugFoam sclerotherapy

    Injection of foam sclerosant into varicose vein tributaries

06

What researchers measure

Primary outcomes

  1. Re-intervention rate

    Re-intervention on varicose vein tributaries during study period

    Time frame: 12 months

Secondary outcomes

  1. Generic quality of life score

    Quality of life score using the EuroQol's EQ-5D \[0=worse quality of life; 1=best quality of life\]

    Time frame: 12 months

  2. Disease-specific quality of life score

    Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) \[0=worse quality of life; 100= best quality of life\]

    Time frame: 12 months

  3. Disease specific quality of life score

    Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) \[0=worse quality of life; 100=best quality of life\]

    Time frame: 12 months

  4. Clinical score

    Clinical change using the Venous Clinical Severity Score (VCSS) \[0=least severe disease; 30=most severe disease\]

    Time frame: 12 months

  5. Clinical score

    Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification \[0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer\]

    Time frame: 12 months

  6. 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)

    Time frame: 2 weeks

  7. 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)

    Time frame: 2 weeks

  8. Time to return to normal activities

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Charing Cross Hospital, Imperial College London
    London, W6 8RF, United Kingdom
    Recruiting
    • Amjad Belramman · Contacta.belramman17@imperial.ac.uk · +442033117335
    • Roshan Bootun · Contactr.bootun@imperial.ac.uk · +442033117335
    • Alun H Davies · Principal investigator
    • Tristan RA Lane · Sub investigator
    • Roshan Bootun · Sub investigator
    • Amjad Belramman · Sub investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2018 (actual). Primary completion is estimated for May 2025, 87 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Jan 31, 2018
StartActual
Feb 1, 2018
Primary completionEst.
May 31, 2025
CompletionEst.
Jun 30, 2025
Last update
Jul 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03416413
Responsible party
Sponsor
First posted
Jan 31, 2018
Start date
Feb 1, 2018
Primary completion
May 31, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jul 5, 2024

Study contacts

Amjad Belramman
Contact
a.belramman17@imperial.ac.uk
02033117335
Roshan Bootun
Contact
r.bootun@imperial.ac.uk
02033117335

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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