Pressure Alternating Shoes (PAS)

The University of Texas System (UT)

Status: Completed

Conditions: Foot Ulcer, Diabetic

Treatments: Device: test pressure alternating shoes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06026813

STU-2022-1038

7R21AG061471-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Healthy controls

Experimental group

Description:

Patients without diabetes who do not have foot wounds or history of amputation

Treatment:

Device: test pressure alternating shoes

Patients with Diabetic Neuropathy

Experimental group

Description:

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

Treatment:

Device: test pressure alternating shoes