Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers

Conditions
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Foot Ulcer, Diabetic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>Patients without diabetes who do not have foot wounds or history of amputation | |
| Patients with Diabetic Neuropathy<br>Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar pressure | Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar skin temperature | Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius) | Baseline | 
| Tissue oxygenation | Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2) | Baseline | 
| Balance | Positional sense measured by body-worn sensors (cm) | Baseline |