CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
test pressure alternating shoesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06026813
NCT06026813N/ACompleted

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

University of Texas Southwestern Medical Center·interventional·Posted Sep 7, 2023·Updated Aug 12, 2025

In Brief

A clinical study evaluating test pressure alternating shoes for Foot Ulcer, Diabetic. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedSep 7, 2023
Enrollment StartMar 7, 2024
Primary CompletionJul 11, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.8 years ago

Interventions

test pressure alternating shoesdevice

test pressure alternating shoes