Status:
COMPLETED
Pressure Alternating Shoes
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
The University of Texas at Arlington
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
NA
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 inso...
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...
Eligibility Criteria
Inclusion
- Healthy Controls:
- Age 18 or greater
- Ability to wear insoles in shoes provided
- Ability to walk unaided
Exclusion
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06026813
Start Date
March 7 2024
End Date
July 11 2024
Last Update
August 12 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8560