Investigation Into the Pathophysiology and Treatment of Varicose Veins

January 3, 2024 updated by: University of Surrey
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins.
Time Frame: 2 years 4 months
no additional details - project ended 2015 and staff have left
2 years 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 2 years 4 months
no additional details - project ended 2015 and staff have left
2 years 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Surrey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Whiteley Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 112453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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