Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy
Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 5, 2024
July 1, 2024
7.3 years
January 24, 2018
July 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Re-intervention rate
Re-intervention on varicose vein tributaries during study period
12 months
Secondary Outcomes (8)
Generic quality of life score
12 months
Disease-specific quality of life score
12 months
Disease specific quality of life score
12 months
Clinical score
12 months
Clinical score
12 months
- +3 more secondary outcomes
Study Arms (2)
Ambulatory Phlebectomy
ACTIVE COMPARATORAmbulatory phlebectomy of varicose vein tributaries
Foam Sclerotherapy
ACTIVE COMPARATORInjection of foam sclerosant into varicose vein tributaries
Interventions
Minor surgery to remove varicose vein tributaries
Eligibility Criteria
You may qualify if:
- Adults over 18 years of age
- Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex
- Varicose vein tributary requiring treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charing Cross Hospital, Imperial College London
London, W6 8RF, United Kingdom
Related Publications (1)
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.
PMID: 31269978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
January 31, 2018
Study Start
February 1, 2018
Primary Completion
May 31, 2025
Study Completion
June 30, 2025
Last Updated
July 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share