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DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency (DESIVI)

Primary Purpose

Varicose Veins, Venous Stasis, Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Revitive IX Neuromuscular Stimulation Device
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Venous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    No device utilised for 6 weeks.

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Venous Flow Parameters - PV
    Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
    Venous Flow Parameters - VF
    Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
    Microcirculatory Blood Flow
    Microcirculatory blood flow measure utilising flux arbitrary units.
    Limb Volume
    Change in limb volume assessed in ml.
    Venous Clinical Severity
    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
    Patient Compliance
    Compliance with device usage assessed with a patient completed diary.
    Generic Quality of Life - EQ-5D-5L
    Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead).
    Generic Quality of Life - SF-12
    Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
    Generic Quality of Life - EQ-VAS
    Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
    Disease Specific Quality of Life
    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.

    Full Information

    First Posted
    February 19, 2019
    Last Updated
    July 13, 2020
    Sponsor
    Imperial College London
    Collaborators
    Actegy Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03850496
    Brief Title
    DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
    Acronym
    DESIVI
    Official Title
    Dosing of Electrical Stimulation in Venous Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London
    Collaborators
    Actegy Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicose Veins, Venous Stasis, Venous Insufficiency
    Keywords
    Venous

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    No Intervention
    Arm Description
    No device utilised for 6 weeks.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Revitive IX Neuromuscular Stimulation Device
    Intervention Description
    Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
    Primary Outcome Measure Information:
    Title
    Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
    Description
    Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
    Time Frame
    0 and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Venous Flow Parameters - PV
    Description
    Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
    Time Frame
    0 and 6 weeks
    Title
    Venous Flow Parameters - VF
    Description
    Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
    Time Frame
    0 and 6 weeks
    Title
    Microcirculatory Blood Flow
    Description
    Microcirculatory blood flow measure utilising flux arbitrary units.
    Time Frame
    0 and 6 weeks.
    Title
    Limb Volume
    Description
    Change in limb volume assessed in ml.
    Time Frame
    0 and 6 weeks
    Title
    Venous Clinical Severity
    Description
    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
    Time Frame
    0 and 6 weeks.
    Title
    Patient Compliance
    Description
    Compliance with device usage assessed with a patient completed diary.
    Time Frame
    6 weeks.
    Title
    Generic Quality of Life - EQ-5D-5L
    Description
    Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead).
    Time Frame
    0 and 6 weeks
    Title
    Generic Quality of Life - SF-12
    Description
    Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
    Time Frame
    0 and 6 weeks
    Title
    Generic Quality of Life - EQ-VAS
    Description
    Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
    Time Frame
    0 and 6 weeks
    Title
    Disease Specific Quality of Life
    Description
    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.
    Time Frame
    0 weeks and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raveena Ravikumar, MRCS
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Available on request.
    IPD Sharing Time Frame
    Post publication.
    IPD Sharing Access Criteria
    On direct communication with researchers.

    Learn more about this trial

    DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

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