Clinical trial NCT06026813: Pressure Alternating Shoes
Official title: Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: The University of Texas at Arlington
First posted: 2023-09-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Plantar pressure
timeFrame: Baseline
Secondary outcomes:
measure: Plantar skin temperature
timeFrame: Baseline
measure: Tissue oxygenation
timeFrame: Baseline
measure: Balance
timeFrame: Baseline
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Peter Crisologo, D.P.M.
role: PRINCIPAL_INVESTIGATOR
References: