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
About this trial
This is an interventional treatment trial for Varicose Veins
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
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
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
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
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