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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: Chemical sclerotherapy; Drug: 1% Sodium Tetradecyl Sulphate; Drug: 3% Sodium Tetradecyl Sulphate; Drug: 0.5% Polidocanol; Drug: 3% Polidcanol

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XH
      • University of Surrey
    • Guildford, Surrey, United Kingdom, GU2 7RF
      • The Whiteley Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gives consent
• Over 18 years
• Undergoing phlebectomy operation

Exclusion Criteria:

• Does not give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Chemical sclerotherapy; Sclerosant will be retained within the vein; Drug: 1% Sodium Tetradecyl Sulphate; 1% Sodium Tetradecyl Sulphate
Experimental: 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.	Procedure: Chemical sclerotherapy; Sclerosant will be retained within the vein; Drug: 3% Sodium Tetradecyl Sulphate; 3% Sodium Tetradecyl Sulphate
Experimental: 0.5% Polidocanol; Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.	Procedure: Chemical sclerotherapy; Sclerosant will be retained within the vein; Drug: 0.5% Polidocanol; 0.5% Polidocanol
Experimental: 3% Polidcanol; Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant.	Procedure: Chemical sclerotherapy; Sclerosant will be retained within the vein; Drug: 3% Polidcanol; 3% Polidcanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins.	no additional details - project ended 2015 and staff have left	2 years 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	no additional details - project ended 2015 and staff have left	2 years 4 months

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: The Whiteley Clinic
• Investigators: Principal Investigator: Christopher T Lee, MPharm, Univesity of Surrey; Study Director: Jian-Mei Li, MBBS MD PhD, University of Surrey; Study Director: Mark S Whiteley, MS, The Whiteley Clinic and University of Surrey

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol; Sodium Tetradecyl Sulfate
• Other Study ID Numbers: 112453