Trial Outcomes & Findings for Electrical Stimulation to Accelerate Wound Healing (NCT NCT03821675)

Results Overview

Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Change at 4 weeks from baseline.

Results posted on

2022-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Active Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Overall Study STARTED	19	19
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Stimulation to Accelerate Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=16 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham n=17 Participants Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.	Total n=33 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 13.8 • n=5 Participants	61.4 years STANDARD_DEVIATION 11.2 • n=7 Participants	63.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change at 4 weeks from baseline.

Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.

Outcome measures

Outcome measures
Measure	Active n=16 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham n=17 Participants Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change in Skin Perfusion in Response to Electrical Stimulation Therapy	65.1 mmHg Standard Deviation 19.1	72.2 mmHg Standard Deviation 18.1

PRIMARY outcome

Timeframe: Change at 4 weeks from baseline

Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.

Outcome measures

Outcome measures
Measure	Active n=16 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham n=17 Participants Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change in Wound Size in Response to Electrical Stimulation Therapy	5.8 cm2 Standard Deviation 8	3.2 cm2 Standard Deviation 8.7

SECONDARY outcome

Timeframe: Change at 4 weeks from baseline.

change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.

Outcome measures

Outcome measures
Measure	Active n=16 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham n=17 Participants Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change in Plantar Sensation in Response to Electrical Stimulation	20.2 Volts Standard Deviation 14	32.1 Volts Standard Deviation 9.2

SECONDARY outcome

Timeframe: Change at 60 minutes from baseline.

Population: Active electrical stimulation was performed during one hour on all participants before randomization.

Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.

Outcome measures

Outcome measures
Measure	Active n=38 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation	73.5 SatO2% Standard Deviation 12.5	—

SECONDARY outcome

Timeframe: Change at 4 weeks from baseline.

Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)

Outcome measures

Outcome measures
Measure	Active n=16 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham n=17 Participants Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change in Tissue Oxygen Saturation in Response to Electrical Stimulation	72.3 SatO2% Standard Deviation 21.5	73.9 SatO2% Standard Deviation 12.1

OTHER_PRE_SPECIFIED outcome

Timeframe: an average of 60 minutes from baseline

Population: Active electrical stimulation was performed during one hour on all participants before randomization.

Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.

Outcome measures

Outcome measures
Measure	Active n=38 Participants Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.	Sham Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Change From Baseline in Skin Perfusion in Response to Electrical Stimulation	79.9 mmHg Standard Deviation 18.3	—

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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

Prof. Bijan Najafi

Baylor College of Medicine

Phone: 17137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60