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NCT Number: NCT03416413

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charing Cross Hospital, Imperial College London

London, W6 8RF, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory phlebectomy

Procedure

Minor surgery to remove varicose vein tributaries

Foam sclerotherapy

Drug

Injection of foam sclerosant into varicose vein tributaries

Primary outcomes

  1. Re-intervention rate

    Time frame: 12 months

    Re-intervention on varicose vein tributaries during study period

Secondary outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2018
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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