NCT03850496

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 4, 2019

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

February 19, 2019

Results QC Date

June 10, 2019

Last Update Submit

July 13, 2020

Conditions

Varicose VeinsVenous StasisVenous Insufficiency

Keywords

Venous

Outcome Measures

Primary Outcomes (1)

  • Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV

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

    0 and 6 weeks

Secondary Outcomes (10)

  • Venous Flow Parameters - PV

    0 and 6 weeks

  • Venous Flow Parameters - VF

    0 and 6 weeks

  • Microcirculatory Blood Flow

    0 and 6 weeks.

  • Limb Volume

    0 and 6 weeks

  • Venous Clinical Severity

    0 and 6 weeks.

  • +5 more secondary outcomes

Study Arms (3)

Group A

NO INTERVENTION

No device utilised for 6 weeks.

Group B

EXPERIMENTAL

Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.

Device: Revitive IX Neuromuscular Stimulation Device

Group C

EXPERIMENTAL

Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.

Device: Revitive IX Neuromuscular Stimulation Device

Interventions

Revitive IX Neuromuscular Stimulation DeviceDEVICE

Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Group BGroup C

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic venous insufficiency who have the following are eligible for the study:
  • Able to understand the study and provide meaningful written informed consent for the study.
  • Willing, able, and committed to participate in the procedures for the full length of the study.
  • All ethnic groups, male or female above the age of 18 years.
  • Diagnosis of chronic venous insufficiency (C3-C5 CEAP Classification)
  • Blood pressure currently under moderate control (\< 160/100mmHg)
  • No current foot ulceration

You may not qualify if:

  • Patients meeting any of the following criteria are to be excluded:
  • Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
  • Pregnant
  • Has a cardiac pacemaker, AICD or other implanted electrical device
  • Has an Existing DVT.
  • Has recent lower limb injury or lower back pain
  • Has current foot ulceration or other skin ulcers
  • Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
  • Has an ABPI \< 0.8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Varicose VeinsVaricose UlcerVenous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr Tristan Lane, Clinical Lecturer
Organization
Imperial College London
tristan.lane@imperial.ac.uk
02033117317

Study Officials

  • Raveena Ravikumar, MRCS

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

February 19, 2019

First Posted

February 21, 2019

Study Start

November 1, 2015

Primary Completion

August 31, 2016

Study Completion

October 31, 2016

Last Updated

July 31, 2020

Results First Posted

September 4, 2019

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Available on request.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Post publication.
Access Criteria
On direct communication with researchers.