Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Phase 4

Recruiting

• Conditions: Varicose Veins
• Interventions: Drug: Foam sclerotherapy; Procedure: Ambulatory phlebectomy

• Registration Number: NCT03416413
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foam Sclerotherapy	Foam sclerotherapy	Injection of foam sclerosant into varicose vein tributaries
Ambulatory Phlebectomy	Ambulatory phlebectomy	Ambulatory phlebectomy of varicose vein tributaries

Primary Outcome Measures

Name	Time	Method
Re-intervention rate	12 months	Re-intervention on varicose vein tributaries during study period

Secondary Outcome Measures

Name	Time	Method
Generic quality of life score	12 months	Quality of life score using the EuroQol's EQ-5D \[0=worse quality of life; 1=best quality of life\]
Disease specific quality of life score	12 months	Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) \[0=worse quality of life; 100=best quality of life\]
Disease-specific quality of life score	12 months	Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) \[0=worse quality of life; 100= best quality of life\]
Degree of bruising at 2 weeks	2 weeks	Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment)
Clinical score	12 months	Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification \[0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer\]
Pain score over the first 10 days	2 weeks	Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
Time to return to normal activities	2 weeks

Trial Locations

Locations (1)

Charing Cross Hospital, Imperial College London; 🇬🇧 London, United Kingdom