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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Varicose Veins
Venous Stasis
Venous Insufficiency
Intervention Device: Revitive IX Neuromuscular Stimulation Device
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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 footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

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

Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Period Title: Overall Study
Started 26 25 25
Completed 25 24 21
Not Completed 1 1 4
Reason Not Completed
Withdrawal by Subject             1             0             0
Lost to Follow-up             0             1             4
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group 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 footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

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

Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Total of all reporting groups
Overall Number of Baseline Participants 26 25 25 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 25 participants 76 participants
59  (5) 59  (5) 63  (5) 60  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 25 participants 76 participants
Female
8
  30.8%
9
  36.0%
12
  48.0%
29
  38.2%
Male
18
  69.2%
16
  64.0%
13
  52.0%
47
  61.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 26 participants 25 participants 25 participants 76 participants
26 25 25 76
1.Primary Outcome
Title Disease Specific Quality of Life Measure - Aberdeen Varicose Vein Questionnaire
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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 footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

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

Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Overall Number of Participants Analyzed 25 24 21
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale (0-100)
Baseline
18.62
(10.13 to 26.83)
21.07
(16.34 to 29.47)
21.30
(11.91 to 31.33)
6 weeks
19.72
(11.30 to 25.38)
18.86
(14.99 to 28.52)
15.01
(11.04 to 21.31)
2.Secondary Outcome
Title Venous Flow Parameters - TAMV
Hide 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 6 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Venous Flow Parameters - PV
Hide Description Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Time Frame 6 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Venous Flow Parameters - VF
Hide Description Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Time Frame 6 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Microcirculatory Blood Flow
Hide Description Microcirculatory blood flow measure utilising flux arbitrary units.
Time Frame 6 weeks.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Limb Volume
Hide Description Change in limb volume assessed in ml.
Time Frame 6 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Venous Clinical Severity
Hide Description Clinical severity of venous disease as measured by the venous clinical severity score (VCSS).
Time Frame 6 weeks.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Patient Compliance
Hide Description Compliance with device usage assessed with a patient completed diary.
Time Frame 6 weeks.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Generic Quality of Life - EQ-5D
Hide Description Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire.
Time Frame 6 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Generic Quality of Life - SF-12
Hide 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 6 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Generic Quality of Life - EQ-VAS
Hide Description Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS
Time Frame 6 weeks
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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 footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

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

Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Tristan Lane, Clinical Lecturer
Organization: Imperial College London
Phone: 02033117317
EMail: tristan.lane@imperial.ac.uk
Layout table for additonal information
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 Submitted: February 19, 2019
First Posted: February 21, 2019
Results First Submitted: June 10, 2019
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019