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NCT03850496: DESIVI

DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Completed NA Results posted Last updated 31 July 2020
What this trial tests

NA trial testing Revitive IX Neuromuscular Stimulation Device in Varicose Veins in 76 participants. Completed in 31 October 2016.

Timeline
1 November 2015
Primary endpoint
31 August 2016
31 October 2016

Quick facts

Lead sponsorImperial College London
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment76
Start date1 November 2015
Primary completion31 August 2016
Estimated completion31 October 2016

Drugs / interventions tested

Conditions studied

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Varicose Veins or Venous Stasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV Primary · 0 and 6 weeks

Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.

0 weeks
GroupValue95% CI
Group A3.36-16.48 – 18.54
Group B26.586.65 – 92.32
Group C39.4920.48 – 99.75
6 weeks
GroupValue95% CI
Group A0.46-20.81 – 12.26
Group B27.838.01 – 70.93
Group C36.386.45 – 108.80
Venous Flow Parameters - PV Secondary · 0 and 6 weeks

Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.

0 Week
GroupValue95% CI
Group A-4.760-25.84 – 12.61
Group B202.782.63 – 247.1
Group C151.9111.3 – 234.7
6 Weeks
GroupValue95% CI
Group A3.360-17.91 – 15.13
Group B145.862.97 – 233.5
Group C246.684.66 – 297.5
Venous Flow Parameters - VF Secondary · 0 and 6 weeks

Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.

0 weeks
GroupValue95% CI
Group A5.525-14.76 – 22.48
Group B28.8116.59 – 87.42
Group C52.8216.99 – 92.54
6 weeks
GroupValue95% CI
Group A-6.145-22.58 – 10.21
Group B29.115.768 – 84.21
Group C52.8216.99 – 92.54
Venous Clinical Severity Secondary · 0 and 6 weeks.

Clinical severity of venous disease as measured by the venous clinical severity score (VCSS). Scale measure from 0-30, with higher values indicating worse status. It is made up of 10 variables scored from 0-3

0 weeks
GroupValue95% CI
Group A64.5 – 8
Group B65 – 8
Group C74.750 – 9.250
6 weeks
GroupValue95% CI
Group A75 – 9.5
Group B54 – 8
Group C32 – 6.5
Disease Specific Quality of Life Secondary · 0 weeks and 6 weeks

quality of life as assessed on the Aberdeen varicose vein questionnaire scale (0-100). This is a patient reported quality of life measure, which assesses symptoms of varicose veins. Higher values are worse.

0 weeks
GroupValue95% CI
Group A18.6210.13 – 26.83
Group B21.0716.34 – 29.47
Group C21.3011.91 – 31.33
6 weeks
GroupValue95% CI
Group A19.7211.30 – 25.38
Group B18.8614.99 – 28.52
Group C15.0111.04 – 21.31

Sponsor's own description

This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status.
    Ravikumar R, Lane TR, Babber A, Onida S, et al · · 2021 · cited 7× · PMID 33176593 · DOI 10.1177/0268355520968640

Verify or expand the search:

Other recruiting trials for Varicose Veins

Currently open trials in the same condition.

Other Imperial College London trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03850496.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing