NCT06026813

Pressure Alternating Shoes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	test pressure alternating shoes	test pressure alternating shoes

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-07-11
• Completion: 2024-07-11
• First posted: 2023-09-07
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study