Pressure Alternating Shoes

NCT06026813 | Completed Results FDA Device

• 2 other identifiers: STU-2022-10387R21AG061471-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (6)

• Maximum Average Pressure at Baseline With Pressure Alternating Shoes, Right Foot (Before Any Cells Were Offloaded)

  Maximum Average pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot.

  Before any cells were offloaded (First 40-seconds of the walk)

• Maximum Average Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device

  Maximum Average pressure values in the plantar regions after offloading cells during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.

  After offloading (approx. 41- 200 seconds walk)

• Peak Interface Pressure at Baseline (Before Offloading) - Diabetic Footwear Equipped With PAS Device

  Peak Interface Pressure values in the plantar regions before offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.

  Baseline (First 40-seconds of the walk)

• Peak Interface Pressure at After Offloading - Diabetic Footwear Equipped With PAS Device

  Peak Interface Pressure values in the plantar regions after offloading during walking. The insole consists of seven air cells that align with specific regions: the big toe (cell 1), the area spanning from the second toe to the fifth toe (cell 2), metatarsal heads (cells 3 and 4), the midfoot (cells 5 and 6), and the heel (cell 7). Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.

  After offloading (approx. 41- 200 seconds walk)

• Max Average Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device

  Percentage change due to offloading for each participant is measured by dividing the pressure difference between the after offloading and before offloading values divided by the before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.

  Baseline (first 40-second walk), 201 seconds after the intervention ended

• Peak Pressure Change Among All Participants - Diabetic Footwear Equipped With PAS Device

  Peak pressure change due to offloading for each participant is measured by dividing the pressure difference between the peak after offloading and peak before offloading values divided by the peak before offloading value. Measurements were only obtained from the right foot. The results reported represent results for footwear with PAS device.

  Baseline (first 40-second walk), 201 seconds after the intervention ended

Secondary Outcomes (11)

• Plantar Skin Temperature at Baseline, Right Foot

  Baseline before the intervention (30 minutes after start of visit 1)

• Plantar Skin Temperature Post Intervention, Right Foot

  Post intervention (215 seconds)

• Tissue Oxygenation (Oxygen Saturation) - for Plantar Lateral Foot

  Baseline (30 minutes after start of visit 1)

• Tissue Oxygenation (Oxyhemoglobin and Deoxyhemoglobin ) - for Plantar Lateral Foot

  Baseline (30 minutes after start of visit 1)

• Tissue Oxygenation (Oxygen Saturation) - for Plantar Medial Foot

  Baseline (30 minutes after start of visit 1)

Study Arms (2)

Healthy controls

EXPERIMENTAL

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

Device: test pressure alternating shoes

Patients with Diabetic Neuropathy

EXPERIMENTAL

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

Device: test pressure alternating shoes

Interventions

test pressure alternating shoes DEVICE

test pressure alternating shoes

Healthy controls; Patients with Diabetic Neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• Ability to wear insoles in shoes provided
• Ability to walk unaided

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Aging (NIA): collaborator
• The University of Texas at Arlington: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8560, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

Ex-PI left institution after enrollment completion in study. Data not collected for 'Balance' outcome due to technical issues involving body worn sensor connectivity. For remaining, outcomes due to technical issues like unexpected stop in interface pressure data collection during testing \& insole control box not functioning properly, it resulted in inability to collect pressure data for 4 healthy subjects \& so not included in analysis.

Results Point of Contact

• Title: Dr. Peter Crisologo
• Organization: UT Southwestern Medical Center

Peter.Crisologo@UTSouthwestern.edu

214/648-7284

Study Officials

• Peter Crisologo, D.P.M.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 7, 2023
• Study Start: March 7, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)