Trial Outcomes & Findings for Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD (NCT NCT04313985)
NCT ID: NCT04313985
Last Updated: 2023-06-01
Results Overview
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
TERMINATED
NA
4 participants
Day 7 of the respective treatment period
2023-06-01
Participant Flow
Participant milestones
| Measure |
Electrical Stimulation First, Then Sham Stimulation
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period.
|
Sham Stimulation First, the Electrical Stimulation
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period.
|
|---|---|---|
|
Treatment Period 1 (1 Week)
STARTED
|
2
|
2
|
|
Treatment Period 1 (1 Week)
COMPLETED
|
2
|
2
|
|
Treatment Period 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (1 Week)
STARTED
|
2
|
2
|
|
Treatment Period 2 (1 Week)
COMPLETED
|
2
|
2
|
|
Treatment Period 2 (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Follow-up Period (1 Week)
STARTED
|
2
|
2
|
|
Follow-up Period (1 Week)
COMPLETED
|
2
|
2
|
|
Follow-up Period (1 Week)
NOT COMPLETED
|
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 |
Electrical Stimulation First, Then Sham Stimulation
n=2 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period.
|
Sham Stimulation First, the Electrical Stimulation
n=2 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Pain Score
|
0 score on a scale
STANDARD_DEVIATION 0 • n=2 Participants
|
2.5 score on a scale
STANDARD_DEVIATION 3.536 • n=2 Participants
|
1.25 score on a scale
STANDARD_DEVIATION 2.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 7 of the respective treatment periodPopulation: Data were not collected for the outcome measure.
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 7 of the respective treatment periodTo compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).
Outcome measures
| Measure |
Electrical Stimulation
n=4 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering electrical stimulation.
|
Sham Electrical Stimulation
n=4 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering no stimulation.
|
|---|---|---|
|
Percent Change in Wound Area as a Measure of Healing Rate
|
-31 percentage change
Interval -71.0 to 19.0
|
-52 percentage change
Interval -65.0 to 38.0
|
SECONDARY outcome
Timeframe: From time of randomization up until wound healing or 3 weeks, whichever came firstPopulation: Data were not collected for this outcome measure.
To compare bacterial burden at the wound site following treatment vs placebo (measured in cells per gram of wound tissue from quantitative deep tissue swab)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 7 of the respective treatment periodTo compare patient pain at the wound site following treatment vs placebo, measured on a numerical 0-10 visual scale (0 = no pain, 10 = worst pain imaginable)
Outcome measures
| Measure |
Electrical Stimulation
n=4 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering electrical stimulation.
|
Sham Electrical Stimulation
n=4 Participants
Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering no stimulation.
|
|---|---|---|
|
Pain Score
|
0 score on a scale
Interval 0.0 to 1.75
|
1 score on a scale
Interval 0.0 to 1.25
|
Adverse Events
Electrical Stimulation
Sham Electrical Stimulation
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