Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Varicose Veins Clinical Trial

Official title:

Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416413
• Other study ID #: 17/WS/0192
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Imperial College London
• Contact: Amjad Belramman
• Phone: 02033117335
• Email: a.belramman17[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Ambulatory phlebectomy
Minor surgery to remove varicose vein tributaries

Drug:
• Foam sclerotherapy
Injection of foam sclerosant into varicose vein tributaries

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital, Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-intervention rate	Re-intervention on varicose vein tributaries during study period	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinical score	Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease]	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to return to normal activities		2 weeks