18 and older, any sex, with Foot Ulcer, Diabetic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)Primary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls
118.5
± 26.4
Patients With Diabetic Neuropathy
113.7
Cell 3
Group
Value
95% CI
Healthy Controls
96.6
± 30.2
Patients With Diabetic Neuropathy
54.9
Cell 4
Group
Value
95% CI
Healthy Controls
83.8
± 20.0
Patients With Diabetic Neuropathy
72.2
Cell 7
Group
Value
95% CI
Healthy Controls
95.2
± 19.0
Patients With Diabetic Neuropathy
92.1
Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS DevicePrimary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
97.6
± 25.7
Patients With Diabetic Neuropathy - Footwear With PAS Device
94.6
Cell 3
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
82.5
± 26.5
Patients With Diabetic Neuropathy - Footwear With PAS Device
48.4
Cell 4
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
70.2
± 18.1
Patients With Diabetic Neuropathy - Footwear With PAS Device
56.6
Cell 7
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
83.2
± 17.3
Patients With Diabetic Neuropathy - Footwear With PAS Device
78.8
Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS DevicePrimary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
146.6
± 28.4
Patients With Diabetic Neuropathy - Footwear With PAS Device
101.8
Cell 3
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
125.1
± 37.5
Patients With Diabetic Neuropathy - Footwear With PAS Device
51.2
Cell 4
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
98.78
± 17.3
Patients With Diabetic Neuropathy - Footwear With PAS Device
64.2
Cell 7
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
107.6
± 20.5
Patients With Diabetic Neuropathy - Footwear With PAS Device
78.3
Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS DevicePrimary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
119.5
± 26.32
Patients With Diabetic Neuropathy - Footwear With PAS Device
85.6
Cell 3
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
105.2
± 32.3
Patients With Diabetic Neuropathy - Footwear With PAS Device
44.7
Cell 4
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
84.21
± 16.4
Patients With Diabetic Neuropathy - Footwear With PAS Device
51.7
Cell 7
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
94.81
± 18.8
Patients With Diabetic Neuropathy - Footwear With PAS Device
64.1
Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS DevicePrimary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
18.1
± 10.4
Patients With Diabetic Neuropathy - Footwear With PAS Device
16.7
Cell 3
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
14.4
± 6.5
Patients With Diabetic Neuropathy - Footwear With PAS Device
11.8
Cell 4
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
16.4
± 6.1
Patients With Diabetic Neuropathy - Footwear With PAS Device
21.6
Cell 7
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
12.8
± 3.4
Patients With Diabetic Neuropathy - Footwear With PAS Device
14.4
Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS DevicePrimary· 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.
Cell 1
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
18.5
± 9.3
Patients With Diabetic Neuropathy - Footwear With PAS Device
15.9
Cell 3
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
15.93
± 6.1
Patients With Diabetic Neuropathy - Footwear With PAS Device
12.6
Cell 4
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
14.67
± 6.8
Patients With Diabetic Neuropathy - Footwear With PAS Device
19.5
Cell 7
Group
Value
95% CI
Healthy Controls - Footwear With PAS Device
11.83
± 4.8
Patients With Diabetic Neuropathy - Footwear With PAS Device
18.0
Plantar Skin Temperature at Baseline, Right FootSecondary· 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
Right foot
Group
Value
95% CI
Healthy Controls
29.64
± 2.16
Patients With Diabetic Neuropathy
34.7
Left foot
Group
Value
95% CI
Healthy Controls
29.73
± 2.07
Patients With Diabetic Neuropathy
35
Plantar Skin Temperature Post Intervention, Right FootSecondary· Post intervention (215 seconds)
Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) post intervention, without footwear
Right foot
Group
Value
95% CI
Healthy Controls
28.7
± 2.04
Patients With Diabetic Neuropathy
32.1
Left foot
Group
Value
95% CI
Healthy Controls
29.35
± 1.62
Patients With Diabetic Neuropathy
32.2
Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral FootSecondary· 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.
Group
Value
95% CI
Overall Subjects in Experimental Group
67.0
64.0 – 72.3
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral FootSecondary· 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. Th
Oxyhemoglobin
Group
Value
95% CI
Overall Subjects in Experimental Group
0.50
0.43 – 0.54
Deoxyhemoglobin
Group
Value
95% CI
Overall Subjects in Experimental Group
0.24
0.20 – 0.25
Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial FootSecondary· 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.
Group
Value
95% CI
Overall Subjects in Experimental Group
71.0
66.8 – 72.5
Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial FootSecondary· 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 ne
Oxyhemoglobin
Group
Value
95% CI
Overall Subjects in Experimental Group
0.46
0.41 – 0.49
Deoxyhemoglobin
Group
Value
95% CI
Overall Subjects in Experimental Group
0.19
0.17 – 0.21
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06026813.