Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: Ambulatory phlebectomy; Drug: Foam sclerotherapy

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amjad Belramman; Phone Number: 02033117335; Email: a.belramman17@imperial.ac.uk
• Study Contact Backup: Name: Roshan Bootun; Phone Number: 02033117335; Email: r.bootun@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Recruiting
    • Charing Cross Hospital, Imperial College London
    • Contact: Amjad Belramman; Phone Number: +442033117335; Email: a.belramman17@imperial.ac.uk
    • Contact: Roshan Bootun; Phone Number: +442033117335; Email: r.bootun@imperial.ac.uk
    • Principal Investigator: Alun H Davies
    • Sub-Investigator: Tristan RA Lane
    • Sub-Investigator: Roshan Bootun
    • Sub-Investigator: Amjad Belramman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambulatory Phlebectomy; Ambulatory phlebectomy of varicose vein tributaries	Procedure: Ambulatory phlebectomy; Minor surgery to remove varicose vein tributaries
Active Comparator: Foam Sclerotherapy; Injection of foam sclerosant into varicose vein tributaries	Drug: Foam sclerotherapy; Injection of foam sclerosant into varicose vein tributaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention rate	Re-intervention on varicose vein tributaries during study period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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]	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]	12 months
Clinical score	Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease]	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]	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)	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)	2 weeks
Time to return to normal activities		2 weeks

Collaborators and Investigators

• Sponsor: Imperial College London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 17/WS/0192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No