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Completed

NCT Number: NCT06192472

Investigation Into the Pathophysiology and Treatment of Varicose Veins

Chemical sclerotherapy is commonly used to treat varicose veins which affect superficial veins in the leg. Sclerotherapy is injected directly into veins where it causes damage to the vein wall. If sufficient damage occurs, the vein is transformed into a fibrous cord which does not re-open. This study will investigate the structural changes caused to the wall of veins following injection with sclerotherapy ex vivo. Vein samples will be obtained from the Whiteley Clinic in Guildford from patients undergoing phlebectomy operations. These will then be injected with sclerotherapy and the extent of damage will be investigated. Samples will also be used for laboratory analysis into the pathophysiology of varicose veins.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Whiteley Clinic, Guildford, Surrey, United Kingdom

Loading trial locations.

About this study

Varicose veins affect up to 40% of the population and are associated with significant discomfort, skin damage, and complications including ulceration and perforation. In recent years, there has been a move towards minimally invasive treatment, including chemical sclerotherapy. Despite their widespread use,the fundamental effects of sclerosants have not been fully characterised. Furthermore, their use is associated with significant rates of re-canalisation and clinical recurrence. There is therefore significant scope for researching the effects of sclerosants on the vein wall and the mechanisms of cell death. Furthermore, the pathophysiology of varicose veins has not been fully characterised. It is the aim of this study to research a number of themes related to the use of sclerotherapy and the pathophysiology of varicose veins in order to provide information which will both further scientific knowledge and further develop clinical practice by optimising the use of sclerotherapy. This research will be conducted by a PhD student based at the University of Surrey, in conjunction with the Whiteley Clinic in Guildford. Veins and blood samples removed following varicose vein surgery at the Whiteley Clinic will be provided for laboratory-based research at the university. A range of methodologies will be employed to analyse cellular responses to sclerosants to determine the precise structural and biochemical changes which lead to destruction of the vein and clinical efficacy, and to investigate a number of key themes implicated in the pathophysiology of varicose veins.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gives consent
  • Over 18 years
  • Undergoing phlebectomy operation

Exclusion criteria

  • Does not give consent

Treatment and study plan

Chemical sclerotherapy

Procedure

Sclerosant will be retained within the vein

1% Sodium Tetradecyl Sulphate

Drug

1% Sodium Tetradecyl Sulphate

3% Sodium Tetradecyl Sulphate

Drug

3% Sodium Tetradecyl Sulphate

0.5% Polidocanol

Drug

0.5% Polidocanol

3% Polidcanol

Drug

3% Polidcanol

Primary outcomes

  1. To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins.

    Time frame: 2 years 4 months

    no additional details - project ended 2015 and staff have left

Secondary outcomes

  1. To gain further insight into the pathological mechanisms underlying varicose vein formation and recurrence, and to identify a biomarker which indicates susceptibility to development of varicose veins.

    Time frame: 2 years 4 months

    no additional details - project ended 2015 and staff have left

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Collaborators

  • The Whiteley Clinic

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2024
Registry last updated
Jan 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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