Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03416413
NCT03416413
Recruiting
Phase 4

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

Imperial College London1 site in 1 country160 target enrollmentFebruary 1, 2018
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVaricose Veins
InterventionsAmbulatory phlebectomyFoam sclerotherapy
DrugsFoam sclerotherapy

Overview

Phase
Phase 4
Intervention
Ambulatory phlebectomy
Conditions
Varicose Veins
Sponsor
Imperial College London
Enrollment
160
Locations
1
Primary Endpoint
Re-intervention rate
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Ambulatory Phlebectomy

Ambulatory phlebectomy of varicose vein tributaries

Intervention: Ambulatory phlebectomy

Foam Sclerotherapy

Injection of foam sclerosant into varicose vein tributaries

Intervention: Foam sclerotherapy

Outcomes

Primary Outcomes

Re-intervention rate

Time Frame: 12 months

Re-intervention on varicose vein tributaries during study period

Secondary Outcomes

  • Generic quality of life score(12 months)
  • Disease specific quality of life score(12 months)
  • Disease-specific quality of life score(12 months)
  • Degree of bruising at 2 weeks(2 weeks)
  • Time to return to normal activities(2 weeks)
  • Pain score over the first 10 days(2 weeks)
  • Clinical score(12 months)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal VaricesVaricose Veins
NCT00991497Gloucestershire Hospitals NHS Foundation Trust124
Completed
Not Applicable
Catheter-directed Foam Sclerotherapy With TumescenceVaricose Vein of Lower Limbs
NCT02753270University of Sao Paulo50
Recruiting
Not Applicable
Finnish Venous Ulcer Study (FINNULCER Study)
NCT04737941Oulu University Hospital248
Completed
Phase 4
Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein VaricosisVaricose Veins
NCT02010723Medical University of Vienna40
Completed
Not Applicable
Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins
ISRCTN51995477niversity of Aberdeen (UK)798