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

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ClinicalTrials.gov Identifier: NCT06026813
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : March 15, 2024
Sponsor:
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

Study Description
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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.

Condition or disease
Foot Ulcer, Diabetic

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers
Actual Study Start Date : March 7, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Plantar pressure [ Time Frame: Baseline ]
    Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)


Secondary Outcome Measures :
  1. Plantar skin temperature [ Time Frame: Baseline ]
    Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius)

  2. Tissue oxygenation [ Time Frame: Baseline ]
    Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)

  3. Balance [ Time Frame: Baseline ]
    Positional sense measured by body-worn sensors (cm)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Healthy controls
  2. Patients with Diabetic Neuropathy
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06026813


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

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8560
Contact: Debby Noble    214-648-8686    debby.noble@utsouthwestern.edu   
Principal Investigator: Lawrence A Lavery, DPM         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Aging (NIA)
The University of Texas at Arlington
More Information
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Responsible Party: Larry Lavery, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT06026813    
Other Study ID Numbers: STU-2022-1038
7R21AG061471-02 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases