NCT06192472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
8.4 years until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

May 20, 2014

Last Update Submit

January 3, 2024

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    2 years 4 months

Study Arms (4)

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.

Procedure: Chemical sclerotherapyDrug: 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.

Procedure: Chemical sclerotherapyDrug: 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.

Procedure: Chemical sclerotherapyDrug: 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.

Procedure: Chemical sclerotherapyDrug: 3% Polidcanol

Interventions

Chemical sclerotherapyPROCEDURE

Sclerosant will be retained within the vein

0.5% Polidocanol1% Sodium Tetradecyl Sulphate3% Polidcanol3% Sodium Tetradecyl Sulphate
1% Sodium Tetradecyl SulphateDRUG

1% Sodium Tetradecyl Sulphate

1% Sodium Tetradecyl Sulphate
3% Sodium Tetradecyl SulphateDRUG

3% Sodium Tetradecyl Sulphate

3% Sodium Tetradecyl Sulphate
0.5% PolidocanolDRUG

0.5% Polidocanol

0.5% Polidocanol
3% PolidcanolDRUG

3% Polidcanol

3% Polidcanol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gives consent
  • Over 18 years
  • Undergoing phlebectomy operation

You may not qualify if:

  • Does not give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Whiteley Clinic

Guildford, Surrey, GU2 7RF, United Kingdom

Location

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Sodium Tetradecyl SulfatePolidocanol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipidsPolyethylene GlycolsEthylene GlycolsGlycolsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Christopher T Lee, MPharm

    Univesity of Surrey

    PRINCIPAL INVESTIGATOR

  • Jian-Mei Li, MBBS MD PhD

    University of Surrey

    STUDY DIRECTOR

  • Mark S Whiteley, MS

    The Whiteley Clinic and University of Surrey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

January 5, 2024

Study Start

April 1, 2013

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

GB(2)