Trial Outcomes & Findings for Venous Insufficiency and Neuromuscular Stimulation (NCT NCT02137499)
NCT ID: NCT02137499
Last Updated: 2019-10-25
Results Overview
Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
baseline, 20 minutes
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
Healthy Subjects
Healthy participants treated with Small transcutaneous electrical stimulator
|
Superficial Venous Insufficiency
Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Insufficiency
Participant with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Obstruction
Participant with Deep venous obstruction treated with Small transcutaneous electrical stimulator
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Subjects
n=10 Participants
Healthy participants treated with Small transcutaneous electrical stimulator
|
Superficial Venous Insufficiency
n=10 Participants
Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Insufficiency
n=10 Participants
Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Obstruction
n=10 Participants
Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 10 • n=10 Participants
|
55 years
STANDARD_DEVIATION 15 • n=10 Participants
|
58.6 years
STANDARD_DEVIATION 18 • n=10 Participants
|
53.2 years
STANDARD_DEVIATION 16 • n=10 Participants
|
56 years
STANDARD_DEVIATION 12 • n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: baseline, 20 minutesDoppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.
Outcome measures
| Measure |
Healthy Subjects
n=10 Participants
Healthy participants treated with Small transcutaneous electrical stimulator
|
Superficial Venous Insufficiency
n=10 Participants
Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Insufficiency
n=10 Participants
Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator
|
Deep Venous Obstruction
n=10 Participants
Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
|
|---|---|---|---|---|
|
Percentage Change of Haemodynamic Flow
Peak velocity
|
34.8 % change
Interval -4.0 to 81.0
|
62.8 % change
Interval 25.0 to 138.0
|
9 % change
Interval -10.0 to 84.0
|
14.8 % change
Interval -8.0 to 51.0
|
|
Percentage Change of Haemodynamic Flow
TAMV time-averaged mean velocity
|
-14.2 % change
Interval -30.0 to 55.0
|
28.1 % change
Interval -2.0 to 111.0
|
28.2 % change
Interval -30.0 to 66.0
|
-5.1 % change
Interval -28.0 to 35.0
|
|
Percentage Change of Haemodynamic Flow
Volume flow
|
-22.5 % change
Interval -40.0 to 40.0
|
37.5 % change
Interval -10.0 to 172.0
|
17.4 % change
Interval 1.0 to 49.0
|
5.9 % change
Interval -11.0 to 21.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Data not collected
Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Data not collected
Measured using ankle and calf circumference, and multiplying using "inverted cone" method
Outcome measures
Outcome data not reported
Adverse Events
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Superficial Venous Insufficiency
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep Venous Insufficiency
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep Venous Obstruction
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place