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Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Primary Purpose

Varicose Veins

Status

Recruiting

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Ambulatory phlebectomy

Foam sclerotherapy

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charing Cross Hospital, Imperial College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ambulatory Phlebectomy

Foam Sclerotherapy

Arm Description

Ambulatory phlebectomy of varicose vein tributaries

Injection of foam sclerosant into varicose vein tributaries

Outcomes

Primary Outcome Measures

Re-intervention rate

Re-intervention on varicose vein tributaries during study period

Secondary Outcome Measures

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]

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]

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]

Clinical score

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

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]

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)

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 to return to normal activities

Full Information

NCT ID

NCT03416413

First Posted

January 24, 2018

Last Updated

August 4, 2022

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT03416413

Brief Title

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Veins

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ambulatory Phlebectomy

Arm Type

Active Comparator

Arm Description

Ambulatory phlebectomy of varicose vein tributaries

Arm Title

Foam Sclerotherapy

Arm Type

Active Comparator

Arm Description

Injection of foam sclerosant into varicose vein tributaries

Intervention Type

Procedure

Intervention Name(s)

Ambulatory phlebectomy

Intervention Description

Minor surgery to remove varicose vein tributaries

Intervention Type

Drug

Intervention Name(s)

Foam sclerotherapy

Intervention Description

Injection of foam sclerosant into varicose vein tributaries

Primary Outcome Measure Information:

Title

Re-intervention rate

Description

Re-intervention on varicose vein tributaries during study period

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Generic quality of life score

Description

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

Time Frame

12 months

Title

Disease-specific quality of life score

Description

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

Title

Disease specific quality of life score

Description

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

Title

Clinical score

Description

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

Time Frame

12 months

Title

Clinical score

Description

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

Title

Pain score over the first 10 days

Description

Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Time Frame

2 weeks

Title

Degree of bruising at 2 weeks

Description

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

Title

Time to return to normal activities

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amjad Belramman

Phone

02033117335

a.belramman17@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Roshan Bootun

Phone

02033117335

r.bootun@imperial.ac.uk

Facility Information:

Facility Name

Charing Cross Hospital, Imperial College London

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact: