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

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ClinicalTrials.gov Identifier: NCT03850496
Recruitment Status : Completed
First Posted : February 21, 2019
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Actegy Ltd.
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Venous Stasis Venous Insufficiency Device: Revitive IX Neuromuscular Stimulation Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dosing of Electrical Stimulation in Venous Insufficiency
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
No Intervention: Group A
No device utilised for 6 weeks.
Experimental: Group B
Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.
Device: Revitive IX Neuromuscular Stimulation Device
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Experimental: Group C
Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.
Device: Revitive IX Neuromuscular Stimulation Device
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.




Primary Outcome Measures :
  1. Disease Specific Quality of Life Measure - Aberdeen Varicose Vein Questionnaire [ Time Frame: 6 weeks ]
    Assessment using the Aberdeen Varicose Vein Questionnaire disease specific questionnaire on quality of life. Assessed at baseline and at 6 weeks. Scored from 0-100. 100 worst 0 best.


Secondary Outcome Measures :
  1. Venous Flow Parameters - TAMV [ Time Frame: 6 weeks ]
    Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.

  2. Venous Flow Parameters - PV [ Time Frame: 6 weeks ]
    Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.

  3. Venous Flow Parameters - VF [ Time Frame: 6 weeks ]
    Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.

  4. Microcirculatory Blood Flow [ Time Frame: 6 weeks. ]
    Microcirculatory blood flow measure utilising flux arbitrary units.

  5. Limb Volume [ Time Frame: 6 weeks ]
    Change in limb volume assessed in ml.

  6. Venous Clinical Severity [ Time Frame: 6 weeks. ]
    Clinical severity of venous disease as measured by the venous clinical severity score (VCSS).

  7. Patient Compliance [ Time Frame: 6 weeks. ]
    Compliance with device usage assessed with a patient completed diary.

  8. Generic Quality of Life - EQ-5D [ Time Frame: 6 weeks ]
    Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire.

  9. Generic Quality of Life - SF-12 [ Time Frame: 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.

  10. Generic Quality of Life - EQ-VAS [ Time Frame: 6 weeks ]
    Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850496


Sponsors and Collaborators
Imperial College London
Actegy Ltd.
Investigators
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Principal Investigator: Raveena Ravikumar, MRCS Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03850496     History of Changes
Other Study ID Numbers: 15HH2472
171441 ( Other Identifier: IRAS Project ID )
15/LO/0620 ( Other Identifier: National Research Ethics Number )
First Posted: February 21, 2019    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available on request.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Post publication.
Access Criteria: On direct communication with researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Venous
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Varicose Ulcer
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases