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Pilot RCT Evaluating a One Stop Vein Clinic (OSVeC)

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ClinicalTrials.gov Identifier: NCT02557542
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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 us with enough information for a potentially larger multicentre randomised controlled study.

Condition or disease Intervention/treatment Phase
Varicose Veins Other: One Stop Vein Clinic Device: Radiofrequency ablation Device: Endovenous laser ablation Drug: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Randomised Controlled Trial Evaluating the Potential Benefit of a One Stop Vein Clinic (OSVeC)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Experimental: One Stop Vein Clinic
Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment
Other: One Stop Vein Clinic
Same day diagnosis and treatment

Device: Radiofrequency ablation
Venous ablation

Device: Endovenous laser ablation
Venous ablation

Drug: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)
Venous ablation

Active Comparator: Normal Care Pathway
Patients randomised to this group will be invited to the Normal Care Pathway
Other: One Stop Vein Clinic
Same day diagnosis and treatment

Device: Radiofrequency ablation
Venous ablation

Device: Endovenous laser ablation
Venous ablation

Drug: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)
Venous ablation




Primary Outcome Measures :
  1. Quality of life years gained [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 3 months ]
    Patient satisfaction using a patient satisfaction questionnaire

  2. Generic quality of life scores using EQ-5D questionnaire [ Time Frame: 3 months ]
    Quality of life questionnaire

  3. Specific quality of life scores using AVVQ [ Time Frame: 3 months ]
    Quality of life questionnaire

  4. Specific quality of life scores using CIVIQ [ Time Frame: 3 months ]
    Quality of life questionnaire

  5. Time from referral to treatment [ Time Frame: 18 weeks ]
  6. Measure the cost of the One Stop Vein clinic compared to the normal care pathway [ Time Frame: 3 months ]
  7. Report the time to return to normal activities and to work [ Time Frame: 1 month ]
  8. Measure the societal costs of the one stop vein clinic [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557542


Contacts
Contact: Roshan Bootun +442033117335 r.bootun@imperial.ac.uk

Locations
United Kingdom
Charing Cross Hospital, Imperial College London Recruiting
London, United Kingdom, W6 8RF
Contact: Roshan Bootun    +442033117335    r.bootun@imperial.ac.uk   
Principal Investigator: Alun H Davies         
Sub-Investigator: Colin Bicknell         
Sub-Investigator: Kaji Sritharan         
Sub-Investigator: Tristan RA Lane         
Sub-Investigator: Roshan Bootun         
Sponsors and Collaborators
Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02557542     History of Changes
Other Study ID Numbers: 14/LO/1295
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2017

Keywords provided by Imperial College London:
Varicose Veins; One Stop Clinic

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Pharmaceutical Solutions