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

• ClinicalTrials.gov Identifier: NCT06026813
• Recruitment Status: Recruiting
• First Posted: September 7, 2023
• Last Update Posted: March 15, 2024
• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Aging (NIA); The University of Texas at Arlington
• Information provided by (Responsible Party): Larry Lavery, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: August 25, 2023
• First Posted Date: September 7, 2023
• Last Update Posted Date: March 15, 2024
• Actual Study Start Date: March 7, 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

Plantar pressure [ Time Frame: Baseline ]

Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2023)

• Plantar skin temperature [ Time Frame: Baseline ]
  Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius)
• Tissue oxygenation [ Time Frame: Baseline ]
  Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)
• Balance [ Time Frame: Baseline ]
  Positional sense measured by body-worn sensors (cm)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers
• Official Title: Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers
• 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Day
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

1. Healthy controls
2. Patients with Diabetic Neuropathy

• Condition: Foot Ulcer, Diabetic
• Intervention: Not Provided

Study Groups/Cohorts

• Healthy controls
  Patients without diabetes who do not have foot wounds or history of amputation
• Patients with Diabetic Neuropathy
  Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2025
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Debby Noble; 214-648-8686; debby.noble@utsouthwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06026813
• Other Study ID Numbers: STU-2022-1038; 7R21AG061471-02 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Larry Lavery, University of Texas Southwestern Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current

Collaborators

• National Institute on Aging (NIA)
• The University of Texas at Arlington

• Investigators: Not Provided
• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: March 2024