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Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

ConditionVaricose Veins
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults over 18 years of age

Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex

Varicose vein tributary requiring treatment

Disqualifiers

Current DVT

Recurrent varicose veins

Arterial disease (ABPI<0.8)

Vein diameter < 3mm

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ambulatory phlebectomy

    Procedure/Surgery

    Minor surgery to remove varicose vein tributaries

  • Foam sclerotherapy

    Drug

    Injection of foam sclerosant into varicose vein tributaries

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Ambulatory PhlebectomyActive comparator 1 intervention
Group B: Foam SclerotherapyActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov
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