N/A N=20 Prevention

Pressure Alternating Shoes

Foot Ulcer, Diabetic

Bottom Line

View on ClinicalTrials.gov: NCT06026813 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded) — 118.5; 113.7; 96.6; 54.9 kPa

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: test pressure alternating shoes (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)	118.5; 113.7; 96.6; 54.9; 83.8; 72.2	—
PRIMARY Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device	97.6; 94.6; 82.5; 48.4; 70.2; 56.6	—
PRIMARY Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device	146.6; 101.8; 125.1; 51.2; 98.78; 64.2	—
PRIMARY Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device	119.5; 85.6; 105.2; 44.7; 84.21; 51.7	—
PRIMARY Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device	18.1; 16.7; 14.4; 11.8; 16.4; 21.6	—
PRIMARY Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device	18.5; 15.9; 15.93; 12.6; 14.67; 19.5	—
SECONDARY Plantar Skin Temperature at Baseline, Right Foot	29.64; 34.7; 29.73; 35	—
SECONDARY Plantar Skin Temperature Post Intervention, Right Foot	28.7; 32.1; 29.35; 32.2	—
SECONDARY Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot	71.0	—
SECONDARY Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot	0.50; 0.21	—
SECONDARY Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot	73.5	—
SECONDARY Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot	0.47; 0.18	—
SECONDARY Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot	71.0	—
SECONDARY Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot	0.50; 0.21	—
SECONDARY Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot	73.5	—
SECONDARY Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin) - for Plantar Medial Foot	0.47; 0.18	—
SECONDARY Balance	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06026813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.