search
Back to results

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
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
January 24, 2018
Last Updated
August 4, 2022
Sponsor
Imperial College London
search

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
No
Studies a U.S. FDA-regulated Device Product
No

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
No
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
Email
a.belramman17@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Roshan Bootun
Phone
02033117335
Email
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:
First Name & Middle Initial & Last Name & Degree
Amjad Belramman
Phone
+442033117335
Email
a.belramman17@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Roshan Bootun
Phone
+442033117335
Email
r.bootun@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Alun H Davies
First Name & Middle Initial & Last Name & Degree
Tristan RA Lane
First Name & Middle Initial & Last Name & Degree
Roshan Bootun
First Name & Middle Initial & Last Name & Degree
Amjad Belramman

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31269978
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

We'll reach out to this number within 24 hrs