Clinical trial NCT05968924: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Official title: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes
Foot Ulcer
Prevention
Innovation
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Podimetrics, Inc.
First posted: 2023-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.

Detailed description: Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of changes in the foot that predict the development of DFU could allow timely intervention to prevent the limb damage that occurs with advanced DFU.

Studies have demonstrated that increased temperature in the foot presage the development of DFU. Temperature changes can accurately be detected by home monitoring devices and predict impending ulceration. Here the study team will test the uptake of novel foot temperature monitoring technology for a future intervention study to determine if a home monitoring device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center (MMC).

The investigator team will conduct a longitudinal study to determine the adherence to an FDA cleared device, Podimetrics, which has been tested in other populations and shown to 1) decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in high risk patients with a history of DFU.

For this study, the study team will identify and enroll patients who are at high risk for DFU. These participants will be identified from the electronic medical record (EMR) and have case report form filled out.

After providing informed consent, study participants will receive the foot mat and obtain training remotely from Podimetrics, which provides a standardized training program.

Participants briefly stand on the mat daily (20 seconds), and the temperature data is automatically sent for analysis to Podimetrics to interpret the information. The participants will be evaluated over a six-month period to measure:

1. Daily use of the technology
2. Secondary outcomes: occurrence of DFU and use of health care resources.

Study participants will be contacted every month by the Einstein investigators to assess foot health. Study participants will be instructed to contact the study team during the study period to inquire if development of any changes in the foot such as the diagnosis of DFU, or if a foot cast is required for offloading, or if participants have any concerns about their feet.

Eligibility criteria: Inclusion Criteria:

1. Type 1 or Type 2 diabetes mellitus
2. Prior treatment of DFU within 24 months
3. Subject had at least one outpatient follow up with a provider after treatment for DFU
4. No active ulcer at time of enrollment
5. Male or female, aged 18-75 yrs
6. Presence of Neuropathy
7. Ambulatory
8. Provision of signed and dated informed consent form
9. Stated willingness to adhere with all study procedures and availability to participate for the duration of the study

Exclusion Criteria:

1. Active diabetic foot ulcer (DFU)
2. Unable to comply with study requirements
3. Prior above-knee amputation (AKA) or below-knee amputation (BKA)

Primary outcomes:
measure: Adherence to use of SmartMat
timeFrame: Six months
Secondary outcomes:
measure: Use of health care facilities
timeFrame: Up to six months
measure: Occurrence of Diabetic Foot Ulcer (DFU)
timeFrame: Up to six months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Johanna Daily, MD
role: PRINCIPAL_INVESTIGATOR
References: