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COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655406
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).

The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.


Condition or disease Intervention/treatment Phase
Varicose Veins Other: Class 2 compression stockings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Compression stockings
Patients randomised to group A will be asked to wear compression stockings for 1 week
Other: Class 2 compression stockings
No Intervention: No compression
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards



Primary Outcome Measures :
  1. Patient's pain score post-procedure using a visual analogue scale (VAS) [ Time Frame: 10 days ]
    Pain score


Secondary Outcome Measures :
  1. Aberdeen Varicose Vein Questionnaire (AVVQ) score [ Time Frame: 6 months ]
    Disease-specific quality of life score

  2. Chronic venous insufficiency (CIVIQ) score [ Time Frame: 6 months ]
    Disease-specific quality of life score

  3. EuroQol's EQ-5D [ Time Frame: 6 months ]
    Generic quality of life score

  4. Venous clinical severity score (VCSS) [ Time Frame: 6 months ]
    Clinical

  5. Occlusion rate [ Time Frame: 6 months ]
    Occlusion rates will be assessed based on a pre-agreed scale

  6. Degree of phlebitis [ Time Frame: 6 months ]
    Extent of phlebitis will be recorded using a scale



Information from the National Library of Medicine

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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 18 years of age
  • Varicose veins suitable for foam sclerotherapy

Exclusion Criteria:

  • Allergic to sclerosant
  • Current DVT
  • Arterial disease (ABPI<0.8)
  • Patients unable to wear compression stockings
  • Patients who are unwilling to participate
  • Inability or unwillingness to complete questionnaires
  • Inability to attend follow-up appointments

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): NCT02655406


Locations
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United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Roshan Bootun Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02655406    
Other Study ID Numbers: 15/NE/0314
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Foam sclerotherapy
Compression
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases