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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026813
• Other study ID #: STU-2022-1038
• Secondary ID: 7R21AG061471-02
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Debby Noble
• Phone: 214-648-8686
• Email: debby.noble[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute on Aging (NIA), The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plantar pressure	Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)	Baseline
Secondary	Plantar skin temperature	Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius)	Baseline
Secondary	Tissue oxygenation	Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)	Baseline
Secondary	Balance	Positional sense measured by body-worn sensors (cm)	Baseline