Pressure Alternating Shoes

NCT ID: NCT06026813

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2024-07-11

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.

Conditions

Foot Ulcer, Diabetic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy controls

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

Group Type: EXPERIMENTAL

test pressure alternating shoes

Intervention Type: DEVICE

test pressure alternating shoes

Patients with Diabetic Neuropathy

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

Group Type: EXPERIMENTAL

test pressure alternating shoes

Intervention Type: DEVICE

test pressure alternating shoes

Interventions

test pressure alternating shoes

test pressure alternating shoes

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

The University of Texas at Arlington

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Crisologo, DPM

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Crisologo, D.P.M.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

7R21AG061471-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU-2022-1038

Identifier Type: -

Identifier Source: org_study_id