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

Not Applicable

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Device: test pressure alternating shoes

• Registration Number: NCT06026813
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2024-03-07
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	test pressure alternating shoes	Patients without diabetes who do not have foot wounds or history of amputation
Patients with Diabetic Neuropathy	test pressure alternating shoes	Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.

Primary Outcome Measures

Name	Time	Method
Plantar pressure	Baseline	Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)

Secondary Outcome Measures

Name	Time	Method
Tissue oxygenation	Baseline	Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)
Plantar skin temperature	Baseline	Plantar skin temperature measured by a noncontact thermal imaging camera (\*Celcius)
Balance	Baseline	Positional sense measured by body-worn sensors (cm)

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States