RecruitingPhase 4NCT03416413

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

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


Sponsor

Imperial College London

Enrollment

160 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults over 18 years of age
  • Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
  • Varicose vein tributary requiring treatment

Exclusion Criteria9

  • 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

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Interventions

PROCEDUREAmbulatory phlebectomy

Minor surgery to remove varicose vein tributaries

DRUGFoam sclerotherapy

Injection of foam sclerosant into varicose vein tributaries


Locations(1)

Charing Cross Hospital, Imperial College London

London, United Kingdom

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NCT03416413


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