Foot Ulcer, Diabetic
Conditions
Brief summary
The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. An automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer on top of each actuator to modulate and distribute the plantar surface pressure as desired will be tested. This device will allow us to simultaneously load and offload select areas of the foot using the active layer by inflating and deflating individual actuators using pressurized air. After offloading, the remaining load will be distributed to other areas with inflated actuators. Automatic modulation will be provided through programmable control hardware which will cyclically relieve mechanical loading based on a prescribed duration and frequency.
Detailed description
The two-tier human subjects study will be conducted to assess the biomechanical characteristics of PAS. In the first tier, we will test PAS in healthy subjects and in the second tier, we will test PAS in Diabetic Neuropathy patients (DN). Subjects will walk on a treadmill in their usual daily shoes for 5 minutes, then with standard diabetic shoes with the PAS insoles for 5 minutes. Subjects will wear body worn sensors that assess position of the body. Subjects will have the temperature of their feet measured via a special camera after walking. Subjects will rest for 30 minute washout period and have the blood flow in the soles of the feet measured via a special camera. 1 healthy subject will undergo MRI of the foot and ankle.
Interventions
DEVICEtest pressure alternating shoes
test pressure alternating shoes
Sponsors
National Institute on Aging (NIA)
The University of Texas at Arlington
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Controls: Inclusion Criteria: * Age 18 or greater * Ability to wear insoles in shoes provided * Ability to walk unaided
Exclusion criteria
* Diabetic Neuropathy * Charcot foot * Knee pain * Previous amputations * Inflammatory diseases such as rheumatoid arthritis * Open wounds, ulcers, sores or blisters on the feet; signs of infection in the feet Diabetic population: Inclusion: * Age 18 or greater * Ability to wear insoles in shoes provided * Ability to walk unaided * Diagnosis of diabetic neuropathy Excluision: * Charcot foot * Knee Pain * Previous amputations * Inflammatory diseases such as rheumatoid arthritis * Open wounds, ulcers, sores or blistesr on the feet; signs of infection in the feet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Before any cells were offloaded (First 40-seconds of the walk) | 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. |
| Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | After offloading (approx. 41- 200 seconds walk) | 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. |
| Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Baseline (First 40-seconds of the walk) | 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. |
| Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | After offloading (approx. 41- 200 seconds walk) | 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. |
| Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Baseline (first 40-second walk), 201 seconds after the intervention ended | 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 Among All Participants - Diabetic Footwear Equipped With PAS Device | Baseline (first 40-second walk), 201 seconds after the intervention ended | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plantar Skin Temperature at Baseline, Right Foot | 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 |
| Balance | Baseline | Positional sense measured by body-worn sensors (cm) |
| Plantar Skin Temperature Post Intervention, Right Foot | Post intervention (215 seconds) | Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) post intervention, without footwear |
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot | Baseline (30 minutes after start of visit 1) | Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear. |
| Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot | Baseline (30 minutes after start of visit 1) | 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. |
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot | Baseline (30 minutes after start of visit 1) | Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear. |
| Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot | Baseline (30 minutes after start of visit 1) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls- Tier 1 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. | 20 |
| 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. | 1 |
| Total | 21 |
Baseline characteristics
| Characteristic | Healthy Controls- Tier 1 | Patients With Diabetic Neuropathy- Tier 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 1 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 1 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African-American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 0 Participants | 15 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 17 Participants | 0 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 1 |
| other Total, other adverse events | 0 / 20 | 0 / 1 |
| serious Total, serious adverse events | 0 / 20 | 0 / 1 |
Outcome results
Primary
Max Average Pressure Change Among All Participants - 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.
Time frame: Baseline (first 40-second walk), 201 seconds after the intervention ended
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 1 | 18.1 percent change | Standard Deviation 10.4 |
| Healthy Controls | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 3 | 14.4 percent change | Standard Deviation 6.5 |
| Healthy Controls | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 4 | 16.4 percent change | Standard Deviation 6.1 |
| Healthy Controls | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 7 | 12.8 percent change | Standard Deviation 3.4 |
| Patients With Diabetic Neuropathy | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 7 | 14.4 percent change | — |
| Patients With Diabetic Neuropathy | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 1 | 16.7 percent change | — |
| Patients With Diabetic Neuropathy | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 4 | 21.6 percent change | — |
| Patients With Diabetic Neuropathy | Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 3 | 11.8 percent change | — |
Primary
Maximum Average Pressure at After Offloading - 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 1 | 97.6 kPa | Standard Deviation 25.7 |
| Healthy Controls | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 3 | 82.5 kPa | Standard Deviation 26.5 |
| Healthy Controls | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 4 | 70.2 kPa | Standard Deviation 18.1 |
| Healthy Controls | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 7 | 83.2 kPa | Standard Deviation 17.3 |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 7 | 78.8 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 1 | 94.6 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 4 | 56.6 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 3 | 48.4 kPa | — |
Primary
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | 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 |
| Healthy Controls | 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 |
| Healthy Controls | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 4 | 83.8 kPa | Standard Deviation 20 |
| Healthy Controls | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 7 | 95.2 kPa | Standard Deviation 19 |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 7 | 92.1 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 1 | 113.7 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 4 | 72.2 kPa | — |
| Patients With Diabetic Neuropathy | Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) | Cell 3 | 54.9 kPa | — |
Primary
Peak Interface Pressure at After Offloading - 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 1 | 119.5 kPa | Standard Deviation 26.32 |
| Healthy Controls | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 4 | 84.21 kPa | Standard Deviation 16.4 |
| Healthy Controls | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 3 | 105.2 kPa | Standard Deviation 32.3 |
| Healthy Controls | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 7 | 94.81 kPa | Standard Deviation 18.8 |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 7 | 64.1 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 1 | 85.6 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 3 | 44.7 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device | Cell 4 | 51.7 kPa | — |
Primary
Peak Interface Pressure at Baseline (Before Offloading) - 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 1 | 146.6 kPa | Standard Deviation 28.4 |
| Healthy Controls | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 3 | 125.1 kPa | Standard Deviation 37.5 |
| Healthy Controls | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 4 | 98.78 kPa | Standard Deviation 17.3 |
| Healthy Controls | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 7 | 107.6 kPa | Standard Deviation 20.5 |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 7 | 78.3 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 1 | 101.8 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 4 | 64.2 kPa | — |
| Patients With Diabetic Neuropathy | Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device | Cell 3 | 51.2 kPa | — |
Primary
Peak Pressure Change Among All Participants - 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.
Time frame: Baseline (first 40-second walk), 201 seconds after the intervention ended
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 1 | 18.5 percent change | Standard Deviation 9.3 |
| Healthy Controls | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 3 | 15.93 percent change | Standard Deviation 6.1 |
| Healthy Controls | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 4 | 14.67 percent change | Standard Deviation 6.8 |
| Healthy Controls | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 7 | 11.83 percent change | Standard Deviation 4.8 |
| Patients With Diabetic Neuropathy | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 7 | 18.0 percent change | — |
| Patients With Diabetic Neuropathy | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 1 | 15.9 percent change | — |
| Patients With Diabetic Neuropathy | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 4 | 19.5 percent change | — |
| Patients With Diabetic Neuropathy | Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device | Cell 3 | 12.6 percent change | — |
Secondary
Balance
Positional sense measured by body-worn sensors (cm)
Time frame: Baseline
Population: 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.
Secondary
Plantar Skin Temperature at Baseline, Right Foot
Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) before the intervention and without footwear
Time frame: Baseline before the intervention (30 minutes after start of visit 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Plantar Skin Temperature at Baseline, Right Foot | Left foot | 29.73 degree Celsius | Standard Deviation 2.07 |
| Healthy Controls | Plantar Skin Temperature at Baseline, Right Foot | Right foot | 29.64 degree Celsius | Standard Deviation 2.16 |
| Patients With Diabetic Neuropathy | Plantar Skin Temperature at Baseline, Right Foot | Right foot | 34.7 degree Celsius | — |
| Patients With Diabetic Neuropathy | Plantar Skin Temperature at Baseline, Right Foot | Left foot | 35 degree Celsius | — |
Secondary
Plantar Skin Temperature Post Intervention, Right Foot
Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) post intervention, without footwear
Time frame: Post intervention (215 seconds)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Plantar Skin Temperature Post Intervention, Right Foot | Right foot | 28.7 degree Celsius | Standard Deviation 2.04 |
| Healthy Controls | Plantar Skin Temperature Post Intervention, Right Foot | Left foot | 29.35 degree Celsius | Standard Deviation 1.62 |
| Patients With Diabetic Neuropathy | Plantar Skin Temperature Post Intervention, Right Foot | Right foot | 32.1 degree Celsius | — |
| Patients With Diabetic Neuropathy | Plantar Skin Temperature Post Intervention, Right Foot | Left foot | 32.2 degree Celsius | — |
Secondary
Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot | 67.0 percentage StO2 |
Secondary
Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot | 71.0 percentage StO2 |
Secondary
Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot | 71.0 percentage StO2 |
Secondary
Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot | 73.5 percentage StO2 |
Secondary
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot | Oxyhemoglobin | 0.50 Arbitrary Units (AU) |
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot | Deoxyhemoglobin | 0.21 Arbitrary Units (AU) |
Secondary
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot | Oxyhemoglobin | 0.50 Arbitrary Units (AU) |
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot | Deoxyhemoglobin | 0.24 Arbitrary Units (AU) |
Secondary
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot | Oxyhemoglobin | 0.47 Arbitrary Units (AU) |
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot | Deoxyhemoglobin | 0.18 Arbitrary Units (AU) |
Secondary
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot | Oxyhemoglobin | 0.46 Arbitrary Units (AU) |
| Healthy Controls | Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot | Deoxyhemoglobin | 0.19 Arbitrary Units (AU) |