Trial Outcomes & Findings for Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study (NCT NCT02783066)

NCT ID: NCT02783066

Last Updated: 2020-08-12

Results Overview

Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: baseline and 4 weeks
• Results posted on: 2020-08-12

Participant Flow

Participant milestones

Measure	"PulseFlow" Group Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Overall Study STARTED	16
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	"PulseFlow" Group Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Overall Study Withdrawal by Subject	13

Baseline Characteristics

Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study

Baseline characteristics by cohort

Measure	"PulseFlow" Group n=16 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Age, Continuous	57.4 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Body mass index (BMI)	31.3 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Lower Extremity Perfusion Change From Baseline to 4 Weeks ulcerated	167 percentage of baseline perfusion Standard Deviation 71
Lower Extremity Perfusion Change From Baseline to 4 Weeks contralateral	75 percentage of baseline perfusion Standard Deviation 51

PRIMARY outcome

Timeframe: baseline

the quality of walking while wearing Pulseflow offflaoding compared to standard offloading

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading Walking speed with Pulse flow offloading	0.59 m/s Standard Deviation 0.20
Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading Walking speed with standard offloading	0.57 m/s Standard Deviation 0.20

SECONDARY outcome

Timeframe: 4 weeks

adherence to wear offloading boot by downloading from the study device to a specific developed software. The measure is the mean number of minutes the offloading boot was worn for over the course of 4 weeks

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Adherence	6791 minutes Standard Deviation 4914

SECONDARY outcome

Timeframe: baselineand and 4 weeks

measuring the size of the wound (W, L,H)

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Wound Size Change From Baseline to 4 Weeks.	-60 percentage of baseline wound area Standard Deviation 37

SECONDARY outcome

Timeframe: baseline

the quality of walking while wearing Pulseflow offflaoding compared to standard offloading

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading standard offlaoding	0.85 m Standard Deviation 0.20
Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading Pulseflow offlaoding	0.88 m Standard Deviation 0.30

SECONDARY outcome

Timeframe: baseline

Limp: the difference in stance percent between right and left feet

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Limp Difference Between Pulseflow Offflaoding and Standard Offloading standard offlaoding	4.38 percentage Standard Deviation 2.96
Limp Difference Between Pulseflow Offflaoding and Standard Offloading Pulseflow offlaoding	2.99 percentage Standard Deviation 2.56

SECONDARY outcome

Timeframe: baseline

Angular Velocity of leg swing during walking for each side

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Peak Swing Angular Velocity offloaded side of standard offloading	172.53 degree per second Standard Deviation 56.85
Peak Swing Angular Velocity contralateral side of standard offloading	178.49 degree per second Standard Deviation 60.31
Peak Swing Angular Velocity offloaded side of pulseflow offloading	191.72 degree per second Standard Deviation 50.52
Peak Swing Angular Velocity contralateral side of pulseflow offloading	166.77 degree per second Standard Deviation 81.65

SECONDARY outcome

Timeframe: baseline

Propulsion time and stance time for each stride is caulcated by wearable sensors. The measure is ratio of propulsion time to stance time as percentage value.

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Ratio of Propulsion Time to Stance Time offloaded side of standard offloading	55 percentage of stance time Standard Deviation 4
Ratio of Propulsion Time to Stance Time contralateral side of standard offloading	60 percentage of stance time Standard Deviation 8
Ratio of Propulsion Time to Stance Time offloaded side of pulseflow offloading	67 percentage of stance time Standard Deviation 4
Ratio of Propulsion Time to Stance Time contralateral side of pulseflow offloading	62 percentage of stance time Standard Deviation 7

SECONDARY outcome

Timeframe: baseline

Center of Mass (COM) sway measured by wearable inertial sensors

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Center of Mass Sway While Wearing Standard Offloading Boot double stance with eyes open	0.18 cm^2 Standard Deviation 0.04
Center of Mass Sway While Wearing Standard Offloading Boot double stance with eyes closed	0.36 cm^2 Standard Deviation 0.04
Center of Mass Sway While Wearing Standard Offloading Boot tandem stance with eyes open	0.38 cm^2 Standard Deviation 0.28
Center of Mass Sway While Wearing Standard Offloading Boot tandem stance with eyes closed	0.74 cm^2 Standard Deviation 0.16

SECONDARY outcome

Timeframe: baseline

center of mass sway measured by a wearable inertial sensor

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Center of Mass Sway While Wearing Pulseflow Offloading double stance with eyes open	0.14 cm^2 Standard Deviation 0.06
Center of Mass Sway While Wearing Pulseflow Offloading double stance with eyes closed	0.46 cm^2 Standard Deviation 0.34
Center of Mass Sway While Wearing Pulseflow Offloading tandem stance with eyes open	0.29 cm^2 Standard Deviation 0.13
Center of Mass Sway While Wearing Pulseflow Offloading tandem stance with eyes closed	0.46 cm^2 Standard Deviation 0.20

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	"PulseFlow" Group n=3 Participants Eligible subjects will try a new offloading boot for 4 weeks Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Peak Forefoot Pressure offloaded side of standard offloading	168.7 Pa Standard Deviation 156.9
Peak Forefoot Pressure contralateral side of standard offloading	276.7 Pa Standard Deviation 105.7
Peak Forefoot Pressure offloaded side of pulseflow offloading	147.0 Pa Standard Deviation 114.3
Peak Forefoot Pressure contralateral side of pulseflow offloading	196.9 Pa Standard Deviation 84.4

Adverse Events

"PulseFlow" Group

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: bijan.najafi@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place