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Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03416413
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Procedure: Ambulatory phlebectomy Drug: Foam sclerotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Ambulatory Phlebectomy
Ambulatory phlebectomy of varicose vein tributaries
Procedure: Ambulatory phlebectomy
Minor surgery to remove varicose vein tributaries

Active Comparator: Foam Sclerotherapy
Injection of foam sclerosant into varicose vein tributaries
Drug: Foam sclerotherapy
Injection of foam sclerosant into varicose vein tributaries

Primary Outcome Measures :
  1. Re-intervention rate [ Time Frame: 12 months ]
    Re-intervention on varicose vein tributaries during study period

Secondary Outcome Measures :
  1. Generic quality of life score [ Time Frame: 12 months ]
    Quality of life score using the EuroQol's EQ-5D [0=worse quality of life; 1=best quality of life]

  2. Disease-specific quality of life score [ Time Frame: 12 months ]
    Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) [0=worse quality of life; 100= best quality of life]

  3. Disease specific quality of life score [ Time Frame: 12 months ]
    Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) [0=worse quality of life; 100=best quality of life]

  4. Clinical score [ Time Frame: 12 months ]
    Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease]

  5. Clinical score [ Time Frame: 12 months ]
    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]

  6. Pain score over the first 10 days [ Time Frame: 2 weeks ]
    Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

  7. Degree of bruising at 2 weeks [ Time Frame: 2 weeks ]
    Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment)

  8. Time to return to normal activities [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03416413

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Contact: Amjad Belramman 02033117335
Contact: Roshan Bootun 02033117335

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United Kingdom
Charing Cross Hospital, Imperial College London Recruiting
London, United Kingdom, W6 8RF
Contact: Amjad Belramman    +442033117335   
Contact: Roshan Bootun    +442033117335   
Principal Investigator: Alun H Davies         
Sub-Investigator: Tristan RA Lane         
Sub-Investigator: Roshan Bootun         
Sub-Investigator: Amjad Belramman         
Sponsors and Collaborators
Imperial College London

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London Identifier: NCT03416413     History of Changes
Other Study ID Numbers: 17/WS/0192
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases