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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Podimetrics SmartMat

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Adults with diabetes mellitus and history of prior diabetic foot ulcer

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High risk Diabetic Foot Ulcer (DFU); Podimetrics smart map	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Use of SmartMat	Participant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted >3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.	Up to six months following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Health Care Facilities	Use of health care facilities will be enumerated based on the number of participants who presented for care over the course of the study. This will include patient visits to the Emergency Room (ER), podiatrist, internist, walk in clinic, and other health care facilities. This outcome will be based on participant self-reporting of visits. The total number of participants who visited a health care facility is summarized.	Up to six months following intervention
Occurrence of Diabetic Foot Ulcer (DFU)	The number of participants who developed DFU during the course of the study is summarized. Diagnosis of DFU was be based on a physical exam.	Up to six months following intervention

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Diabetes Association; Podimetrics, Inc.
• Investigators: Principal Investigator: Johanna Daily, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642.
• Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028.
• Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.
• Hoban C, Sareen J, Henriksen CA, Kuzyk L, Embil JM, Trepman E. Mental health issues associated with foot complications of diabetes mellitus. Foot Ankle Surg. 2015 Mar;21(1):49-55. doi: 10.1016/j.fas.2014.09.007. Epub 2014 Sep 22.
• Isaac AL, Swartz TD, Miller ML, Short DJ, Wilson EA, Chaffo JL, Watson ES, Hu H, Petersen BJ, Bloom JD, Neff NJ, Linders DR, Salgado SJ, Locke JL, Horberg MA. Lower resource utilization for patients with healed diabetic foot ulcers during participation in a prevention program with foot temperature monitoring. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001440. doi: 10.1136/bmjdrc-2020-001440.
• Margolis DJ, Malay DS, Hoffstad OJ, Leonard CE, MaCurdy T, de Nava KL, Tan Y, Molina T, Siegel KL. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. 2011 Feb 17. In: Data Points Publication Series [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011-. Data Points #2. Available from http://www.ncbi.nlm.nih.gov/books/NBK65149/
• Rothenberg GM, Page J, Stuck R, Spencer C, Kaplan L, Gordon I. Remote Temperature Monitoring of the Diabetic Foot: From Research to Practice. Fed Pract. 2020 Mar;37(3):114-124.
• Skafjeld A, Iversen MM, Holme I, Ribu L, Hvaal K, Kilhovd BK. A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial. BMC Endocr Disord. 2015 Oct 9;15:55. doi: 10.1186/s12902-015-0054-x.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Prevention; Chronic wounds; Foot Ulcer; Innovation; Diabetic complications; Remote temperature monitoring technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Diabetes Complications
• Other Study ID Numbers: 2023-14915; P30DK111022 (U.S. NIH Grant/Contract); CDTR #5 (Other Grant/Funding Number: American Diabetes Association); 342843 (Other Grant/Funding Number: NY Regional Center for Diabetes Translational Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes