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Investigation Into the Pathophysiology and Treatment of Varicose Veins

U

University of Surrey

Status

Completed

Conditions

Varicose Veins

Treatments

Drug: 3% Sodium Tetradecyl Sulphate
Drug: 1% Sodium Tetradecyl Sulphate
Procedure: Chemical sclerotherapy
Drug: 3% Polidcanol
Drug: 0.5% Polidocanol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Gives consent
  • Over 18 years
  • Undergoing phlebectomy operation

Exclusion criteria

  • Does not give consent

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 4 patient groups

1% Sodium Tetradecyl Sulphate
Experimental group
Description:
Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.
Treatment:
Drug: 1% Sodium Tetradecyl Sulphate
Procedure: Chemical sclerotherapy
3% Sodium Tetradecyl Sulphate
Experimental group
Description:
Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.
Treatment:
Procedure: Chemical sclerotherapy
Drug: 3% Sodium Tetradecyl Sulphate
0.5% Polidocanol
Experimental group
Description:
Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.
Treatment:
Drug: 0.5% Polidocanol
Procedure: Chemical sclerotherapy
3% Polidcanol
Experimental group
Description:
Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.
Treatment:
Drug: 3% Polidcanol
Procedure: Chemical sclerotherapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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