NCT02655406

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

4.1 years

First QC Date

January 12, 2016

Last Update Submit

August 4, 2022

Conditions

Varicose Veins

Keywords

Foam sclerotherapyCompression

Outcome Measures

Primary Outcomes (1)

  • Patient's pain score post-procedure using a visual analogue scale (VAS)

    Pain score

    10 days

Secondary Outcomes (6)

  • Aberdeen Varicose Vein Questionnaire (AVVQ) score

    6 months

  • Chronic venous insufficiency (CIVIQ) score

    6 months

  • EuroQol's EQ-5D

    6 months

  • Venous clinical severity score (VCSS)

    6 months

  • Occlusion rate

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Compression stockings

ACTIVE COMPARATOR

Patients randomised to group A will be asked to wear compression stockings for 1 week

Other: Class 2 compression stockings

No compression

NO INTERVENTION

Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards

Interventions

Class 2 compression stockingsOTHER
Compression stockings

Eligibility Criteria

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

You may qualify if:

  • Adults over 18 years of age
  • Varicose veins suitable for foam sclerotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Roshan Bootun

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

January 1, 2016

Primary Completion

January 31, 2020

Study Completion

August 1, 2021

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)