Trial Outcomes & Findings for Pressure Alternating Shoes (NCT NCT06026813)
NCT ID: NCT06026813
Last Updated: 2025-08-12
Results Overview
Maximum Average pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot.
COMPLETED
NA
21 participants
Before any cells were offloaded (First 40-seconds of the walk)
2025-08-12
Participant Flow
Due to design \& device constraints, unable to randomize between left/right foot (PAS device) between subjects \& were asked to walk with daily shoes on treadmill-5 mins (Control data). Order of sessions (PAS \& Daily footwear) weren't randomized as in crossover study. After testing PAS device, daily footwear use data was collected in healthy subjects (Tier 1). Study procedures (use of PAS and daily footwear) in Tier 2- diabetic neuropathic subjects followed the same sequence as in Tier 1.
Participant milestones
| Measure |
Healthy Controls (Tier 1)
Patients without diabetes who do not have foot wounds or history of amputation.
Pressure alternating shoe insoles were placed in both the right and left post-operative shoes. Both insoles were inflated to the same pressure to prevent uneven foot elevation and promote stabilization. However, only the right-side insole was connected to the control box to inflate and offload air cells during the test. Due to design and device constraints, we were unable to randomize between the left or right foot between subjects. Although the protocol mentions diabetic footwear, this is a broad phrase that encompasses post operative shoes as there are many real-world patients who use post operative shoes as their footwear. Subjects were then asked to walk with their daily shoes on the treadmill for 5 minutes (Control data). The order of these sessions / sequence (PAS and Daily footwear) were not randomized as in a cross-over study. After testing PAS device, daily footwear (control data) was collected in health subjects (Tier 1). No amendment to the protocol was made for the change in study flow. This was a minor deviation, and we have completed a deviation form for the same and filed it within the study binder.
|
Patients With Diabetic Neuropathy (Tier 2)
Patients with diagnosed diabetes and neuropathy with superficial ulcers and/or history of surgery/partial amputation.
Pressure alternating shoe insoles were placed in both the right and left post-operative shoes. Both insoles were inflated to the same pressure to prevent uneven foot elevation and promote stabilization. However, only the right-side insole was connected to the control box to inflate and offload air cells during the test (5 mins). Due to design and device constraints, we were unable to randomize between the left or right foot between subjects. Subjects were then asked to walk with their daily shoes on the treadmill for 5 minutes (Control data). The order of these sessions / sequence (PAS and Daily footwear) were not randomized as in a cross-over study. After testing PAS device, daily footwear (control data) was collected in diabetic neuropathic subjects (Tier 2). No amendment to the protocol was made for the change in study flow. This was a minor deviation, and we have completed a deviation form for the same and filed it within the study binder.
|
|---|---|---|
|
Session 1- Tier 1 Subjects(5 Mins)
STARTED
|
20
|
0
|
|
Session 1- Tier 1 Subjects(5 Mins)
COMPLETED
|
20
|
0
|
|
Session 1- Tier 1 Subjects(5 Mins)
NOT COMPLETED
|
0
|
0
|
|
Session 2-Tier 2 Subjects(5 Mins)
STARTED
|
0
|
1
|
|
Session 2-Tier 2 Subjects(5 Mins)
COMPLETED
|
0
|
1
|
|
Session 2-Tier 2 Subjects(5 Mins)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pressure Alternating Shoes
Baseline characteristics by cohort
| Measure |
Healthy Controls- Tier 1
n=20 Participants
Pressure alternating shoe insoles were placed in both the right and left post-operative shoes. Both insoles were inflated to the same pressure to prevent uneven foot elevation and promote stabilization. However, only the right-side insole was connected to the control box to inflate and offload air cells during the test. Due to design and device constraints, we were unable to randomize between the left or right foot between subjects. Although the protocol mentions diabetic footwear, this is a broad phrase that encompasses post operative shoes as there are many real-world patients who use post operative shoes as their footwear. Subjects were then asked to walk with their daily shoes on the treadmill for 5 minutes (Control data). The order of these sessions / sequence (PAS and Daily footwear) were not randomized as in a cross-over study. After testing PAS device, daily footwear (control data) was collected in health subjects (Tier 1). No amendment to the protocol was made for the change in study flow. This was a minor deviation, and we have completed a deviation form for the same and filed it within the study binder.
|
Patients With Diabetic Neuropathy- Tier 2
n=1 Participants
Patients with diagnosed diabetes and neuropathy with superficial ulcers and/or history of surgery/partial amputation.
Pressure alternating shoe insoles were placed in both the right and left post-operative shoes. Both insoles were inflated to the same pressure to prevent uneven foot elevation and promote stabilization. However, only the right-side insole was connected to the control box to inflate and offload air cells during the test (5 mins). Due to design and device constraints, we were unable to randomize between the left or right foot between subjects. Subjects were then asked to walk with their daily shoes on the treadmill for 5 minutes (Control data). The order of these sessions / sequence (PAS and Daily footwear) were not randomized as in a cross-over study. After testing PAS device, daily footwear (control data) was collected in diabetic neuropathic subjects (Tier 2). No amendment to the protocol was made for the change in study flow. This was a minor deviation, and we have completed a deviation form for the same and filed it within the study binder.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before any cells were offloaded (First 40-seconds of the walk)Population: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported.
Maximum Average pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
Cell 1
|
118.5 kPa
Standard Deviation 26.4
|
113.7 kPa
|
|
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
Cell 3
|
96.6 kPa
Standard Deviation 30.2
|
54.9 kPa
|
|
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
Cell 4
|
83.8 kPa
Standard Deviation 20.0
|
72.2 kPa
|
|
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
Cell 7
|
95.2 kPa
Standard Deviation 19.0
|
92.1 kPa
|
PRIMARY outcome
Timeframe: After offloading (approx. 41- 200 seconds walk)Population: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported. This outcome was only assessed for subjects (in both Tiers) with Diabetic Footwear Equipped With PAS Device.
Maximum Average pressure values in the plantar regions after offloading cells during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 1
|
97.6 kPa
Standard Deviation 25.7
|
94.6 kPa
|
|
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 3
|
82.5 kPa
Standard Deviation 26.5
|
48.4 kPa
|
|
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 4
|
70.2 kPa
Standard Deviation 18.1
|
56.6 kPa
|
|
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 7
|
83.2 kPa
Standard Deviation 17.3
|
78.8 kPa
|
PRIMARY outcome
Timeframe: Baseline (First 40-seconds of the walk)Population: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported. This outcome was only assessed for subjects (in both Tiers) with Diabetic Footwear Equipped With PAS Device.
Peak Interface Pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device
Cell 1
|
146.6 kPa
Standard Deviation 28.4
|
101.8 kPa
|
|
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device
Cell 3
|
125.1 kPa
Standard Deviation 37.5
|
51.2 kPa
|
|
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device
Cell 4
|
98.78 kPa
Standard Deviation 17.3
|
64.2 kPa
|
|
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device
Cell 7
|
107.6 kPa
Standard Deviation 20.5
|
78.3 kPa
|
PRIMARY outcome
Timeframe: After offloading (approx. 41- 200 seconds walk)Population: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported. This outcome was only assessed for subjects (in both Tiers) with Diabetic Footwear Equipped With PAS Device.
Peak Interface Pressure values in the plantar regions after offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 1
|
119.5 kPa
Standard Deviation 26.32
|
85.6 kPa
|
|
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 3
|
105.2 kPa
Standard Deviation 32.3
|
44.7 kPa
|
|
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 4
|
84.21 kPa
Standard Deviation 16.4
|
51.7 kPa
|
|
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device
Cell 7
|
94.81 kPa
Standard Deviation 18.8
|
64.1 kPa
|
PRIMARY outcome
Timeframe: Baseline (first 40-second walk), 201 seconds after the intervention endedPopulation: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported. This outcome was only assessed for subjects (in both Tiers) with Diabetic Footwear Equipped With PAS Device.
Percentage change due to offloading for each participant is measured by dividing the pressure difference between the after offloading and before offloading values divided by the before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 1
|
18.1 percent change
Standard Deviation 10.4
|
16.7 percent change
|
|
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 3
|
14.4 percent change
Standard Deviation 6.5
|
11.8 percent change
|
|
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 4
|
16.4 percent change
Standard Deviation 6.1
|
21.6 percent change
|
|
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 7
|
12.8 percent change
Standard Deviation 3.4
|
14.4 percent change
|
PRIMARY outcome
Timeframe: Baseline (first 40-second walk), 201 seconds after the intervention endedPopulation: Due to technical issues like unexpected stop in the interface pressure data collection during testing and insole control box not functioning properly, resulted in incomplete data collection for 4 healthy subjects and therefore not included in the analysis of this outcome measure. All successfully collected data are reported. This outcome was only assessed for subjects (in both Tiers) with Diabetic Footwear Equipped With PAS Device.
Peak pressure change due to offloading for each participant is measured by dividing the pressure difference between the peak after offloading and peak before offloading values divided by the peak before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 1
|
18.5 percent change
Standard Deviation 9.3
|
15.9 percent change
|
|
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 3
|
15.93 percent change
Standard Deviation 6.1
|
12.6 percent change
|
|
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 4
|
14.67 percent change
Standard Deviation 6.8
|
19.5 percent change
|
|
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device
Cell 7
|
11.83 percent change
Standard Deviation 4.8
|
18.0 percent change
|
SECONDARY outcome
Timeframe: Baseline before the intervention (30 minutes after start of visit 1)Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) before the intervention and without footwear
Outcome measures
| Measure |
Healthy Controls
n=20 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Plantar Skin Temperature at Baseline, Right Foot
Right foot
|
29.64 degree Celsius
Standard Deviation 2.16
|
34.7 degree Celsius
|
|
Plantar Skin Temperature at Baseline, Right Foot
Left foot
|
29.73 degree Celsius
Standard Deviation 2.07
|
35 degree Celsius
|
SECONDARY outcome
Timeframe: Post intervention (215 seconds)Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) post intervention, without footwear
Outcome measures
| Measure |
Healthy Controls
n=20 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
n=1 Participants
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Plantar Skin Temperature Post Intervention, Right Foot
Right foot
|
28.7 degree Celsius
Standard Deviation 2.04
|
32.1 degree Celsius
|
|
Plantar Skin Temperature Post Intervention, Right Foot
Left foot
|
29.35 degree Celsius
Standard Deviation 1.62
|
32.2 degree Celsius
|
SECONDARY outcome
Timeframe: Baseline (30 minutes after start of visit 1)Population: We gathered and assessed measurements of the plantar lateral foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot
|
67.0 percentage StO2
Interval 64.0 to 72.3
|
—
|
SECONDARY outcome
Timeframe: Baseline (30 minutes after start of visit 1)Population: We gathered and assessed measurements of the plantar lateral foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar foot tissue oxygenation (Oxyhemoglobin and Deoxyhemoglobin) is measured by noncontact hyperspectral imaging (HSI) camera. Only the right foot was analyzed and without footwear. The accepted measure of oxyhemoglobin and deoxyhemoglobin is arbitrary units (AU). NIR spectrum light passes through skin and is reflected off the blood supplying the tissue. Wavelength dependent light absorption of hemoglobin differs if it is carrying oxygen or not, therefore detecting oxygenated and deoxygenated blood. This was derived from Beer-Lambert Law but would need to be verified by the manufacturer. There is no researcher drawn calculation as the device provides the arbitrary unit based on the reflectance detected back to the imaging device. No reference values or any standardization available but one would infer higher oxyhemoglobin level indicates better oxygenation and thus a higher deoxyhemoglobin would be indicative of poor oxygenation.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
Oxyhemoglobin
|
0.50 Arbitrary Units (AU)
Interval 0.43 to 0.54
|
—
|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
Deoxyhemoglobin
|
0.24 Arbitrary Units (AU)
Interval 0.2 to 0.25
|
—
|
SECONDARY outcome
Timeframe: Baseline (30 minutes after start of visit 1)Population: We gathered and assessed measurements of the plantar medial foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot
|
71.0 percentage StO2
Interval 66.8 to 72.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (30 minutes after start of visit 1)Population: We gathered and assessed measurements of the plantar medial foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar medial foot tissue oxygenation (Oxyhemoglobin and Deoxyhemoglobin) is measured by noncontact hyperspectral imaging (HSI) camera. Only the right foot was analyzed. Only the right foot was analyzed and without footwear. The accepted measure of oxyhemoglobin and deoxyhemoglobin is arbitrary units (AU). NIR spectrum light passes through skin and is reflected off the blood supplying the tissue. Wavelength dependent light absorption of hemoglobin differs if it is carrying oxygen or not, therefore detecting oxygenated and deoxygenated blood. This was derived from Beer-Lambert Law but would need to be verified by the manufacturer. There is no researcher drawn calculation as the device provides the arbitrary unit based on the reflectance detected back to the imaging device. No reference values or any standardization available but one would infer higher oxyhemoglobin level indicates better oxygenation and thus a higher deoxyhemoglobin would be indicative of poor oxygenation.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
Oxyhemoglobin
|
0.46 Arbitrary Units (AU)
Interval 0.41 to 0.49
|
—
|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
Deoxyhemoglobin
|
0.19 Arbitrary Units (AU)
Interval 0.17 to 0.21
|
—
|
SECONDARY outcome
Timeframe: Post Gait (approx. 2015 seconds post intervention)Population: We gathered and assessed measurements of the plantar lateral foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot
|
71.0 percentage StO2
Interval 65.3 to 73.8
|
—
|
SECONDARY outcome
Timeframe: Post Gait (approx. 2015 seconds post intervention)Population: We gathered and assessed measurements of the plantar lateral foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar foot tissue oxygenation (Oxyhemoglobin and Deoxyhemoglobin) is measured by noncontact hyperspectral imaging (HSI) camera. Only the right foot was analyzed and without footwear. The accepted measure of oxyhemoglobin and deoxyhemoglobin is arbitrary units (AU). NIR spectrum light passes through skin and is reflected off the blood supplying the tissue. Wavelength dependent light absorption of hemoglobin differs if it is carrying oxygen or not, therefore detecting oxygenated and deoxygenated blood. This was derived from Beer-Lambert Law but would need to be verified by the manufacturer. There is no researcher drawn calculation as the device provides the arbitrary unit based on the reflectance detected back to the imaging device. No reference values or any standardization available but one would infer higher oxyhemoglobin level indicates better oxygenation and thus a higher deoxyhemoglobin would be indicative of poor oxygenation.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
Oxyhemoglobin
|
0.50 Arbitrary Units (AU)
Interval 0.42 to 0.59
|
—
|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
Deoxyhemoglobin
|
0.21 Arbitrary Units (AU)
Interval 0.18 to 0.24
|
—
|
SECONDARY outcome
Timeframe: Post Gait (approx. 2015 seconds post intervention)Population: We gathered and assessed measurements of the plantar medial foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot
|
73.5 percentage StO2
Interval 67.3 to 76.0
|
—
|
SECONDARY outcome
Timeframe: Post Gait (approx. 2015 seconds post intervention)Population: We gathered and assessed measurements of the plantar medial foot at baseline for both healthy and diabetic participants combined that is reported here.
Plantar medial foot tissue oxygenation (Oxyhemoglobin and Deoxyhemoglobin) is measured by noncontact hyperspectral imaging (HSI) camera. Only the right foot was analyzed and without footwear. The accepted measure of oxyhemoglobin and deoxyhemoglobin is arbitrary units (AU). NIR spectrum light passes through skin and is reflected off the blood supplying the tissue. Wavelength dependent light absorption of hemoglobin differs if it is carrying oxygen or not, therefore detecting oxygenated and deoxygenated blood. This was derived from Beer-Lambert Law but would need to be verified by the manufacturer. There is no researcher drawn calculation as the device provides the arbitrary unit based on the reflectance detected back to the imaging device. No reference values or any standardization available but one would infer higher oxyhemoglobin level indicates better oxygenation and thus a higher deoxyhemoglobin would be indicative of poor oxygenation.
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Patients without diabetes who do not have foot wounds or history of amputation
|
Patients With Diabetic Neuropathy
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
|
|---|---|---|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
Oxyhemoglobin
|
0.47 Arbitrary Units (AU)
Interval 0.38 to 0.52
|
—
|
|
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
Deoxyhemoglobin
|
0.18 Arbitrary Units (AU)
Interval 0.15 to 0.21
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not able to be collected and were considered invalid due to an equipment malfunction (technical difficulties with the sensors).Therefore, this technical issue prevented an assessment and collection of the data.
Positional sense measured by body-worn sensors (cm)
Outcome measures
Outcome data not reported
Adverse Events
Healthy Controls
Patients With Diabetic Neuropathy
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