Investigation Into the Pathophysiology and Treatment of Varicose Veins

NCT ID: NCT06192472

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed 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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1% Sodium Tetradecyl Sulphate

Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.

Group Type: EXPERIMENTAL

Chemical sclerotherapy

Intervention Type: PROCEDURE

Sclerosant will be retained within the vein

1% Sodium Tetradecyl Sulphate

Intervention Type: DRUG

1% Sodium Tetradecyl Sulphate

3% Sodium Tetradecyl Sulphate

Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.

Group Type: EXPERIMENTAL

Chemical sclerotherapy

Intervention Type: PROCEDURE

Sclerosant will be retained within the vein

3% Sodium Tetradecyl Sulphate

Intervention Type: DRUG

3% Sodium Tetradecyl Sulphate

0.5% Polidocanol

Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.

Group Type: EXPERIMENTAL

Chemical sclerotherapy

Intervention Type: PROCEDURE

Sclerosant will be retained within the vein

0.5% Polidocanol

Intervention Type: DRUG

0.5% Polidocanol

3% Polidcanol

Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.

Group Type: EXPERIMENTAL

Chemical sclerotherapy

Intervention Type: PROCEDURE

Sclerosant will be retained within the vein

3% Polidcanol

Intervention Type: DRUG

3% Polidcanol

Interventions

Chemical sclerotherapy

Sclerosant will be retained within the vein

Intervention Type: PROCEDURE

1% Sodium Tetradecyl Sulphate

1% Sodium Tetradecyl Sulphate

Intervention Type: DRUG

3% Sodium Tetradecyl Sulphate

3% Sodium Tetradecyl Sulphate

Intervention Type: DRUG

0.5% Polidocanol

0.5% Polidocanol

Intervention Type: DRUG

3% Polidcanol

3% Polidcanol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Gives consent
• Over 18 years
• Undergoing phlebectomy operation

Exclusion Criteria

• Does not give consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Whiteley Clinic

OTHER

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher T Lee, MPharm

Role: PRINCIPAL_INVESTIGATOR

Univesity of Surrey

Jian-Mei Li, MBBS MD PhD

Role: STUDY_DIRECTOR

University of Surrey

Mark S Whiteley, MS

Role: STUDY_DIRECTOR

The Whiteley Clinic and University of Surrey

Locations

The Whiteley Clinic

Guildford, Surrey, United Kingdom

University of Surrey

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

112453

Identifier Type: -

Identifier Source: org_study_id