NCT02114307

Brief Summary

To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
5 years until next milestone

Results Posted

Study results publicly available

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

April 11, 2014

Results QC Date

June 17, 2019

Last Update Submit

September 20, 2019

Conditions

Venous InsufficiencyOedemaVaricose Veins

Keywords

electrical stimulationvenous insufficiencypost thrombotic syndromevaricose veins

Outcome Measures

Primary Outcomes (1)

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

    Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity

    0 and 6 weeks

Secondary Outcomes (2)

  • Changes in Limb Swelling, Volume

    0 and 6 weeks

  • Clinical Symptoms

    0 and 6 weeks

Study Arms (2)

REVITIVE IX: actual device

ACTIVE COMPARATOR

Trial participants will receive the true Revitive IX device

Device: REVITIVE IX

REVITIVE IX: sham device

SHAM COMPARATOR

Trial participants will receive a sham device

Device: REVITIVE IX

Interventions

REVITIVE IXDEVICE

neuromuscular electrical stimulation device

REVITIVE IX: actual deviceREVITIVE IX: sham device

Eligibility Criteria

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

You may qualify if:

  • Ability 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 (C2-C5 CEAP classified)
  • Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
  • Blood pressure currently under moderate control (\<160/100mmHg)
  • No current foot ulceration.

You may not qualify if:

  • Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
  • Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
  • Has any metal implants.
  • Pregnant.
  • Has a cardiac pacemaker, AICD or other implanted electrical device.
  • Has an existing DVT.
  • Has an acute medical condition other than chronic venous insufficiency.
  • Has recent lower limb injury or lower back pain.
  • Has current foot ulceration or other skin ulcers.
  • Has cardiovascular disease.
  • Has foot deformities.
  • 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

Study Sites (1)

Academic Department of Vascular Surgery, Charing Cross Hospital

London, W4 8RF, United Kingdom

Location

Related Publications (1)

  • Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.

    PMID: 27919609RESULT

MeSH Terms

Conditions

Venous InsufficiencyEdemaVaricose VeinsPostthrombotic Syndrome

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVenous ThrombosisThrombosisEmbolism and Thrombosis

Results Point of Contact

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

Study Officials

  • Alun Davies, MA DM FRCS FHEA

    Imperial College London and Imperial College London NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 15, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 10, 2019

Results First Posted

October 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Data available on request.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
12 Months after publication of main study
Access Criteria
From listed authors.

Locations

GB(1)