An interventional study of test pressure alternating shoes in Foot Ulcer, Diabetic, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
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Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Healthy Controls:
Inclusion Criteria:
Exclusion Criteria:
Diabetic population:
Inclusion:
Excluision:
Patients without diabetes who do not have foot wounds or history of amputation
Device: test pressure alternating shoes
Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
Device: test pressure alternating shoes
test pressure alternating shoes
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)
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)
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Balance
Positional sense measured by body-worn sensors (cm)
Time frame: Baseline
| Milestone | Healthy Controls (Tier 1) | Patients With Diabetic Neuropathy (Tier 2) |
|---|---|---|
| Started | 20 | 0 |
| Completed | 20 | 0 |
| Not completed | 0 | 0 |
| Milestone | Healthy Controls (Tier 1) | Patients With Diabetic Neuropathy (Tier 2) |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
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.
| kPa | Healthy Controls | Patients With Diabetic Neuropathy |
|---|---|---|
| Cell 1 | 118.5 ± 26.4 | 113.7 |
| Cell 3 | 96.6 ± 30.2 | 54.9 |
| Cell 4 | 83.8 ± 20.0 | 72.2 |
| Cell 7 | 95.2 ± 19.0 | 92.1 |
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.
| kPa | Healthy Controls - Footwear With PAS Device | Patients With Diabetic Neuropathy - Footwear With PAS Device |
|---|---|---|
| Cell 1 | 97.6 ± 25.7 | 94.6 |
| Cell 3 | 82.5 ± 26.5 | 48.4 |
| Cell 4 | 70.2 ± 18.1 | 56.6 |
| Cell 7 | 83.2 ± 17.3 | 78.8 |
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.
| kPa | Healthy Controls - Footwear With PAS Device | Patients With Diabetic Neuropathy - Footwear With PAS Device |
|---|---|---|
| Cell 1 | 146.6 ± 28.4 | 101.8 |
| Cell 3 | 125.1 ± 37.5 | 51.2 |
| Cell 4 | 98.78 ± 17.3 | 64.2 |
| Cell 7 | 107.6 ± 20.5 | 78.3 |
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.
| kPa | Healthy Controls - Footwear With PAS Device | Patients With Diabetic Neuropathy - Footwear With PAS Device |
|---|---|---|
| Cell 1 | 119.5 ± 26.32 | 85.6 |
| Cell 3 | 105.2 ± 32.3 | 44.7 |
| Cell 4 | 84.21 ± 16.4 | 51.7 |
| Cell 7 | 94.81 ± 18.8 | 64.1 |
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.
| percent change | Healthy Controls - Footwear With PAS Device | Patients With Diabetic Neuropathy - Footwear With PAS Device |
|---|---|---|
| Cell 1 | 18.1 ± 10.4 | 16.7 |
| Cell 3 | 14.4 ± 6.5 | 11.8 |
| Cell 4 | 16.4 ± 6.1 | 21.6 |
| Cell 7 | 12.8 ± 3.4 | 14.4 |
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.
| percent change | Healthy Controls - Footwear With PAS Device | Patients With Diabetic Neuropathy - Footwear With PAS Device |
|---|---|---|
| Cell 1 | 18.5 ± 9.3 | 15.9 |
| Cell 3 | 15.93 ± 6.1 | 12.6 |
| Cell 4 | 14.67 ± 6.8 | 19.5 |
| Cell 7 | 11.83 ± 4.8 | 18.0 |
Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) before the intervention and without footwear
| degree Celsius | Healthy Controls | Patients With Diabetic Neuropathy |
|---|---|---|
| Right foot | 29.64 ± 2.16 | 34.7 |
| Left foot | 29.73 ± 2.07 | 35 |
Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius) post intervention, without footwear
| degree Celsius | Healthy Controls | Patients With Diabetic Neuropathy |
|---|---|---|
| Right foot | 28.7 ± 2.04 | 32.1 |
| Left foot | 29.35 ± 1.62 | 32.2 |
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
| percentage StO2 | Overall Subjects in Experimental Group |
|---|---|
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot | 67.0 (64.0 to 72.3) |
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.
| Arbitrary Units (AU) | Overall Subjects in Experimental Group |
|---|---|
| Oxyhemoglobin | 0.50 (0.43 to 0.54) |
| Deoxyhemoglobin | 0.24 (0.20 to 0.25) |
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
| percentage StO2 | Overall Subjects in Experimental Group |
|---|---|
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot | 71.0 (66.8 to 72.5) |
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.
| Arbitrary Units (AU) | Overall Subjects in Experimental Group |
|---|---|
| Oxyhemoglobin | 0.46 (0.41 to 0.49) |
| Deoxyhemoglobin | 0.19 (0.17 to 0.21) |
Plantar foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
| percentage StO2 | Overall Subjects in Experimental Group |
|---|---|
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot | 71.0 (65.3 to 73.8) |
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.
| Arbitrary Units (AU) | Overall Subjects in Experimental Group |
|---|---|
| Oxyhemoglobin | 0.50 (0.42 to 0.59) |
| Deoxyhemoglobin | 0.21 (0.18 to 0.24) |
Plantar Medial foot tissue oxygenation (Oxygen saturation) is measured by noncontact hyperspectral imaging camera (StO2). Only the right foot was analyzed and without footwear.
| percentage StO2 | Overall Subjects in Experimental Group |
|---|---|
| Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot | 73.5 (67.3 to 76.0) |
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.
| Arbitrary Units (AU) | Overall Subjects in Experimental Group |
|---|---|
| Oxyhemoglobin | 0.47 (0.38 to 0.52) |
| Deoxyhemoglobin | 0.18 (0.15 to 0.21) |
Positional sense measured by body-worn sensors (cm)
No measurements were reported for this outcome.
Collected over approximately 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Controls | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Patients With Diabetic Neuropathy | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Healthy Controls- Tier 1 | Patients With Diabetic Neuropathy- Tier 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 1 | 21 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Healthy Controls- Tier 1 | Patients With Diabetic Neuropathy- Tier 2 | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 17 | 0 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Controls- Tier 1 | Patients With Diabetic Neuropathy- Tier 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 0 | 5 |
| Not Hispanic or Latino | 15 | 1 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Healthy Controls- Tier 1 | Patients With Diabetic Neuropathy- Tier 2 | Total |
|---|---|---|---|
| Asian | 4 | 0 | 4 |
| Caucasian | 15 | 0 | 15 |
| African-American | 1 | 0 | 1 |
| Black | 0 | 1 | 1 |
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University of Texas Southwestern Medical Center