Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30DK111022 | U.S. NIH Grant/Contract | View source | |
| CDTR #5 | Other Grant/Funding Number | American Diabetes Association | |
| 342843 | Other Grant/Funding Number | NY Regional Center for Diabetes Translational Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Podimetrics, Inc. | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| American Diabetes Association | OTHER |
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk Diabetic Foot Ulcer (DFU) | Experimental | Podimetrics smart map |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Podimetrics SmartMat | 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. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johanna Daily, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18060924 | Background | 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. | |
| 34059410 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study cohort was drawn from a regional referral center for diabetic foot complications, receiving referrals from vascular surgery, endocrinology, emergency room, primary care physicians, other podiatrists, orthopedics, infectious disease and home care nursing teams across multiple Montefiore Medical Center campus locations. The cohort was intended to reflect the broad racial, ethnic, and socioeconomic diversity of the Bronx, consistent with the borough's overall demographics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Risk Diabetic Foot Ulcer (DFU) | Podimetrics smart map 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Risk Diabetic Foot Ulcer (DFU) | Podimetrics smart map 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | number of foot scans/week | Up to six months following intervention |
|
|
Approximately six months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Risk Diabetic Foot Ulcer (DFU) | Podimetrics smart map 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Foot Temperature | Infections and infestations | Non-systematic Assessment |
This study has limitations. The absence of a control group precludes assessment of the mat's efficacy in predicting DFU occurrences, limiting causal inference, which may limit generalizability of adherence to broader high-risk populations. Participant's adherence to offloading instructions was not systematically assessed and may represent a key factor influencing ulcer development despite recommended offloading.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johanna Daily | Montefiore Medical Center | 7188780020 | johanna.daily@einsteinmed.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2024 | Mar 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2024 | Mar 24, 2026 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 25682407 | Background | 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. |
| 33055233 | Background | 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. |
| 15504999 | Background | 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. |
| 22049565 | Background | 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/ |
| 32317847 | Background | 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. |
| 26452544 | Background | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to six months following intervention |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to six months following intervention |
|
|
|
| Post-Hoc | The Number of Re-engagement Calls Per Participant Over the 6-month Study Period | The number of re-engagement calls per participant over the 6-month study period is summarized using basic descriptive statistics. Participants were called each month to determine if there was any diabetic foot ulcer development or utilization of health care facilities (corresponding study outcome measures). Increases in foot temperature (i.e., increase in 2.2 degrees Celsius over two consecutive uses between and of six contralaterally sites), a marker for early ulcer, also triggered a call to the study participant. | Posted | Median | Inter-Quartile Range | calls per participant | Up to six months following intervention |
|
|
|
| 1 |
| 20 |
| 6 |
| 20 |
| 16 |
| 20 |
| Hospitalization | General disorders | Non-systematic Assessment |
|
| Diabetic Foot Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pre-ulcerative hyperkeratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Non-systematic Assessment | Secondary to diabetic foot ulcer |
|
Not provided
Not provided
Not provided
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |