Clinical trial NCT06192472: Investigation Into the Pathophysiology and Treatment of Varicose Veins
Official title: Investigation Into the Pathophysiology and Treatment of Varicose Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: The Whiteley Clinic
First posted: 2024-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Gives consent
* Over 18 years
* Undergoing phlebectomy operation

Exclusion Criteria:

* Does not give consent

Primary outcomes:
measure: To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins.
timeFrame: 2 years 4 months
Secondary outcomes:
measure: 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.
timeFrame: 2 years 4 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
state: Surrey
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
affiliation: Univesity of Surrey
name: Christopher T Lee, MPharm
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Surrey
name: Jian-Mei Li, MBBS MD PhD
role: STUDY_DIRECTOR
affiliation: The Whiteley Clinic and University of Surrey
name: Mark S Whiteley, MS
role: STUDY_DIRECTOR
References: