NCT02557542

Brief Summary

A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of patients This will be a pilot study which is designed to provide enough information for a potentially larger multicentre randomised controlled study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 26, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

5.4 years

First QC Date

August 26, 2015

Results QC Date

May 26, 2023

Last Update Submit

April 30, 2025

Conditions

Varicose Veins

Keywords

Varicose Veins; One Stop Clinic

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Using EuroQoL EQ-5D

    Quality of life using the EuroQoL EQ-5D scale which is a generic quality of life score. Minimum score = -0.073 (worse) and maximum score is 1.0 (best).

    3 months

Secondary Outcomes (7)

  • Patient Satisfaction

    3 months

  • Generic Quality of Life Scores Using EQ-5D Questionnaire

    3 months

  • Specific Quality of Life Scores Using AVVQ

    3 months

  • Time From Referral to Treatment

    18 weeks

  • Measure the Cost of the One Stop Vein Clinic Compared to the Normal Care Pathway

    3 months

  • +2 more secondary outcomes

Study Arms (2)

One Stop Vein Clinic

EXPERIMENTAL

Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment

Other: One Stop Vein ClinicDevice: Radiofrequency ablationDevice: Endovenous laser ablationDrug: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)

Normal Care Pathway

ACTIVE COMPARATOR

Patients randomised to this group will be invited to the Normal Care Pathway

Other: One Stop Vein ClinicDevice: Radiofrequency ablationDevice: Endovenous laser ablationDrug: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)

Interventions

One Stop Vein ClinicOTHER

Same day diagnosis and treatment

Normal Care PathwayOne Stop Vein Clinic
Radiofrequency ablationDEVICE

Venous ablation

Normal Care PathwayOne Stop Vein Clinic
Endovenous laser ablationDEVICE

Venous ablation

Normal Care PathwayOne Stop Vein Clinic
Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)DRUG

Venous ablation

Normal Care PathwayOne Stop Vein Clinic

Eligibility Criteria

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

You may qualify if:

  • Adults over the age of 18 years
  • Unilateral lower limb symptoms suggestive of venous disease on the referral letter

You may not qualify if:

  • Recurrent varicose veins
  • Known arterial disease or ABPI\<0.8
  • Current deep vein thrombosis
  • Patients who withdraw their consent
  • Inability to complete the questionnaire or attend follow up appointments
  • Currently enrolled in other venous study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital, Imperial College London

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Radiofrequency AblationPolidocanolSodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativePolyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureFatty AlcoholsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipids

Results Point of Contact

Title
Mr Roshan Bootun
Organization
Imperial College London
r.bootun@imperial.ac.uk
+442033117335

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 23, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 16, 2025

Results First Posted

May 16, 2025

Record last verified: 2025-04

Locations

GB(1)