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Completed

NCT Number: NCT03850496

DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Vascular Diseases Venous Insufficiency Venous Stasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revitive IX Neuromuscular Stimulation Device

Device

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

Primary outcomes

  1. Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV

    Time frame: 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.

Secondary outcomes

  1. Venous Flow Parameters - PV

    Time frame: 0 and 6 weeks

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

  2. Venous Flow Parameters - VF

    Time frame: 0 and 6 weeks

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

  3. Microcirculatory Blood Flow

    Time frame: 0 and 6 weeks.

    Microcirculatory blood flow measure utilising flux arbitrary units.

  4. Limb Volume

    Time frame: 0 and 6 weeks

    Change in limb volume assessed in ml.

  5. Venous Clinical Severity

    Time frame: 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

  6. Patient Compliance

    Time frame: 6 weeks.

    Compliance with device usage assessed with a patient completed diary.

  7. Generic Quality of Life - EQ-5D-5L

    Time frame: 0 and 6 weeks

    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).

  8. Generic Quality of Life - SF-12

    Time frame: 0 and 6 weeks

    Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.

  9. Generic Quality of Life - EQ-VAS

    Time frame: 0 and 6 weeks

    Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.

  10. Disease Specific Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Actegy Ltd.

Registry information

Official study title

Dosing of Electrical Stimulation in Venous Insufficiency

Acronym: DESIVI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2019
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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