Trial Outcomes & Findings for DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency (NCT NCT03850496)
NCT ID: NCT03850496
Last Updated: 2020-07-31
Results Overview
Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
0 and 6 weeks
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
Group A
No device utilised for 6 weeks.
|
Group B
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.
|
Group C
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 Study
STARTED
|
26
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Group A
No device utilised for 6 weeks.
|
Group B
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.
|
Group C
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 Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=26 Participants
No device utilised for 6 weeks.
|
Group B
n=25 Participants
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.
|
Group C
n=25 Participants
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
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 5 • n=26 Participants
|
59 years
STANDARD_DEVIATION 5 • n=25 Participants
|
63 years
STANDARD_DEVIATION 5 • n=25 Participants
|
60 years
STANDARD_DEVIATION 5 • n=76 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=26 Participants
|
9 Participants
n=25 Participants
|
12 Participants
n=25 Participants
|
29 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=26 Participants
|
16 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
47 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=26 Participants
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
76 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 0 and 6 weeksAssessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
Outcome measures
| Measure |
Group A
n=25 Participants
No device utilised for 6 weeks.
|
Group B
n=24 Participants
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.
|
Group C
n=21 Participants
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.
|
|---|---|---|---|
|
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
0 weeks
|
3.36 percentage change from device off
Interval -16.48 to 18.54
|
26.58 percentage change from device off
Interval 6.65 to 92.32
|
39.49 percentage change from device off
Interval 20.48 to 99.75
|
|
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
6 weeks
|
0.46 percentage change from device off
Interval -20.81 to 12.26
|
27.83 percentage change from device off
Interval 8.01 to 70.93
|
36.38 percentage change from device off
Interval 6.45 to 108.8
|
SECONDARY outcome
Timeframe: 0 and 6 weeksAssessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Outcome measures
| Measure |
Group A
n=25 Participants
No device utilised for 6 weeks.
|
Group B
n=24 Participants
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.
|
Group C
n=21 Participants
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.
|
|---|---|---|---|
|
Venous Flow Parameters - PV
0 Week
|
-4.760 percentage change from device off
Interval -25.84 to 12.61
|
202.7 percentage change from device off
Interval 82.63 to 247.1
|
151.9 percentage change from device off
Interval 111.3 to 234.7
|
|
Venous Flow Parameters - PV
6 Weeks
|
3.360 percentage change from device off
Interval -17.91 to 15.13
|
145.8 percentage change from device off
Interval 62.97 to 233.5
|
246.6 percentage change from device off
Interval 84.66 to 297.5
|
SECONDARY outcome
Timeframe: 0 and 6 weeksAssessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Outcome measures
| Measure |
Group A
n=25 Participants
No device utilised for 6 weeks.
|
Group B
n=24 Participants
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.
|
Group C
n=21 Participants
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.
|
|---|---|---|---|
|
Venous Flow Parameters - VF
0 weeks
|
5.525 percentage change from device off
Interval -14.76 to 22.48
|
28.81 percentage change from device off
Interval 16.59 to 87.42
|
52.82 percentage change from device off
Interval 16.99 to 92.54
|
|
Venous Flow Parameters - VF
6 weeks
|
-6.145 percentage change from device off
Interval -22.58 to 10.21
|
29.11 percentage change from device off
Interval 5.768 to 84.21
|
52.82 percentage change from device off
Interval 16.99 to 92.54
|
SECONDARY outcome
Timeframe: 0 and 6 weeks.Microcirculatory blood flow measure utilising flux arbitrary units.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 and 6 weeksChange in limb volume assessed in ml.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Group A
n=25 Participants
No device utilised for 6 weeks.
|
Group B
n=24 Participants
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.
|
Group C
n=21 Participants
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.
|
|---|---|---|---|
|
Venous Clinical Severity
0 weeks
|
6 Units on a scale
Interval 4.5 to 8.0
|
6 Units on a scale
Interval 5.0 to 8.0
|
7 Units on a scale
Interval 4.75 to 9.25
|
|
Venous Clinical Severity
6 weeks
|
7 Units on a scale
Interval 5.0 to 9.5
|
5 Units on a scale
Interval 4.0 to 8.0
|
3 Units on a scale
Interval 2.0 to 6.5
|
SECONDARY outcome
Timeframe: 6 weeks.Compliance with device usage assessed with a patient completed diary.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 and 6 weeksQuality 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 and 6 weeksQuality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 and 6 weeksQuality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeks and 6 weeksquality 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.
Outcome measures
| Measure |
Group A
n=25 Participants
No device utilised for 6 weeks.
|
Group B
n=24 Participants
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.
|
Group C
n=21 Participants
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.
|
|---|---|---|---|
|
Disease Specific Quality of Life
0 weeks
|
18.62 units on a scale
Interval 10.13 to 26.83
|
21.07 units on a scale
Interval 16.34 to 29.47
|
21.30 units on a scale
Interval 11.91 to 31.33
|
|
Disease Specific Quality of Life
6 weeks
|
19.72 units on a scale
Interval 11.3 to 25.38
|
18.86 units on a scale
Interval 14.99 to 28.52
|
15.01 units on a scale
Interval 11.04 to 21.31
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Tristan Lane, Clinical Lecturer
Imperial College London
Phone: 02033117317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place