Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2025-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

NCT02579070

Diabetic Foot

COMPLETED NA

Diabetic Foot Ulcer Imaging- Study 2

NCT03942081

Foot Ulcer Foot Ulcer, Diabetic

RECRUITING NA

A Predictive Technology for Prevention of Diabetic Foot Ulcers

NCT04769115

Diabetic Foot Ulcer

COMPLETED NA

Foot Intervention Study Utilizing Commercially Available Infrared Thermometers With Individuals With Diabetes

NCT03506776

Diabetic Foot

COMPLETED NA

Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

NCT06782386

Diabetic Foot Ulcer (DFU)

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High risk Diabetic Foot Ulcer (DFU)

Podimetrics smart map

Group Type EXPERIMENTAL

Podimetrics SmartMat

Intervention Type DEVICE

Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Podimetrics SmartMat

Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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