Varicose VeinsNCT06192472
Investigation Into the Pathophysiology and Treatment of Varicose Veins
A study testing Chemical sclerotherapy, 1% Sodium Tetradecyl Sulphate and 3% Sodium Tetradecyl Sulphate in people with Varicose Veins, run by University of Surrey at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Chemical sclerotherapy, 1% Sodium Tetradecyl Sulphate and 3% Sodium Tetradecyl Sulphate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gives consent
- Over 18 years
- Undergoing phlebectomy operation
Who cannot join
- Does not give consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Whiteley Clinic
Guildford, Surrey, GU2 7RF
University of Surrey
Guildford, Surrey, GU2 7XH
About this study
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.
Read the 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
- Being tested
- Chemical sclerotherapy, 1% Sodium Tetradecyl Sulphate, 3% Sodium Tetradecyl Sulphate, 0.5% Polidocanol, 3% Polidcanol
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical sclerotherapyProcedure or surgery
Sclerosant will be retained within the vein
1% Sodium Tetradecyl SulphateDrug
1% Sodium Tetradecyl Sulphate
3% Sodium Tetradecyl SulphateDrug
3% Sodium Tetradecyl Sulphate
0.5% PolidocanolDrug
0.5% Polidocanol
3% PolidcanolDrug
3% Polidcanol
| Study group | Role | What they receive |
|---|---|---|
| 1% Sodium Tetradecyl Sulphate | Experimental | Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. Receives: Procedure: Chemical sclerotherapy; Drug: 1% Sodium Tetradecyl Sulphate |
| 3% Sodium Tetradecyl Sulphate | Experimental | Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. Receives: Procedure: Chemical sclerotherapy; Drug: 3% Sodium Tetradecyl Sulphate |
| 0.5% Polidocanol | Experimental | Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. Receives: Procedure: Chemical sclerotherapy; Drug: 0.5% Polidocanol |
| 3% Polidcanol | Experimental | Superficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. Receives: Procedure: Chemical sclerotherapy; Drug: 3% Polidcanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins.
no additional details - project ended 2015 and staff have left
Measured: 2 years 4 months
Secondary outcomes (1)
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
Measured: 2 years 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study startApr 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- The Whiteley Clinic
- Responsible party
- Sponsor
- Investigators
- Christopher T Lee, MPharm, Principal investigator, Univesity of SurreyJian-Mei Li, MBBS MD PhD, Study director, University of SurreyMark S Whiteley, MS, Study director, The Whiteley Clinic and University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192472
- Sponsor's protocol ID
- 112453
- Status last verified
- Jan 2024
- First submitted
- 20 May 2014
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Pathophysiology and Treatment of Varicose Veins
- ClinicalTrials.gov ID
- NCT06192472
- Acronym / sponsor ID
- 112453
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- The Whiteley Clinic
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1% Sodium Tetradecyl Sulphate | Experimental | Procedure: Chemical sclerotherapy, Drug: 1% Sodium Tetradecyl SulphateSuperficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. |
| 3% Sodium Tetradecyl Sulphate | Experimental | Procedure: Chemical sclerotherapy, Drug: 3% Sodium Tetradecyl SulphateSuperficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. |
| 0.5% Polidocanol | Experimental | Procedure: Chemical sclerotherapy, Drug: 0.5% PolidocanolSuperficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. |
| 3% Polidcanol | Experimental | Procedure: Chemical sclerotherapy, Drug: 3% PolidcanolSuperficial leg veins will be removed by phlebectomy operations. Sections of vein 3-5cm in length will be filled with sclerosant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gives consent
- Over 18 years
- Undergoing phlebectomy operation
Key exclusion criteria (1 listed)
- Does not give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemical sclerotherapySclerosant will be retained within the vein | Procedure or surgery | 0.5% Polidocanol, 1% Sodium Tetradecyl Sulphate, 3% Polidcanol, 3% Sodium Tetradecyl Sulphate |
| 1% Sodium Tetradecyl Sulphate1% Sodium Tetradecyl Sulphate | Drug | 1% Sodium Tetradecyl Sulphate |
| 3% Sodium Tetradecyl Sulphate3% Sodium Tetradecyl Sulphate | Drug | 3% Sodium Tetradecyl Sulphate |
| 0.5% Polidocanol0.5% Polidocanol | Drug | 0.5% Polidocanol |
| 3% Polidcanol3% Polidcanol | Drug | 3% Polidcanol |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher T Lee, MPharm principal investigator
Univesity of Surrey
Jian-Mei Li, MBBS MD PhD study director
University of Surrey
Mark S Whiteley, MS study director
The Whiteley Clinic and University of Surrey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemical sclerotherapy, 1% Sodium Tetradecyl Sulphate and 3% Sodium Tetradecyl Sulphate in people with Varicose Veins, run by University of Surrey at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the mechanisms responsible for the therapeutic effects of sclerotherapy in varicose veins. (time frame: 2 years 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.