Investigation Into the Pathophysiology and Treatment of Varicose Veins

Varicose Veins Clinical Trial

Official title:

Investigation Into the Pathophysiology and Treatment of Varicose Veins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06192472
• Other study ID #: 112453
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2024
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Gives consent

• Over 18 years

• Undergoing phlebectomy operation

Exclusion Criteria:

• Does not give consent

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Chemical sclerotherapy
Sclerosant will be retained within the vein

Drug:
• 1% Sodium Tetradecyl Sulphate
1% Sodium Tetradecyl Sulphate
• 3% Sodium Tetradecyl Sulphate
3% Sodium Tetradecyl Sulphate
• 0.5% Polidocanol
0.5% Polidocanol
• 3% Polidcanol
3% Polidcanol

Locations

Country	Name	City	State
United Kingdom	The Whiteley Clinic	Guildford	Surrey
United Kingdom	University of Surrey	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	The Whiteley Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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