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.

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.

Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.

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.

Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.

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.

Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.

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.

Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.

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.

Positional sense measured by body-worn sensors (cm)

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 of all reporting groups

Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.

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.

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.

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.

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.

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.

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.

Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius) before the intervention and without footwear

Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius) post intervention, without footwear

Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.

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.

We gathered and assessed measurements of the plantar lateral 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.

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.

We gathered and assessed measurements of the plantar medial 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.

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.

We gathered and assessed measurements of the plantar lateral 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.

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.

We gathered and assessed measurements of the plantar medial foot at baseline for both healthy and diabetic participants combined that is reported here.

Positional sense measured by body-worn sensors (cm)

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.

Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.