Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, Foot Ulcer, Prevention, Innovation, Diabetic complications, Remote temperature monitoring technology, Chronic wounds
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.
Interventions
DEVICEPodimetrics 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.
Sponsors
Montefiore Medical Center
Podimetrics, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Use of SmartMat | Up to six months following intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Health Care Facilities | Up to six months following intervention | 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. |
| Occurrence of Diabetic Foot Ulcer (DFU) | Up to six months following intervention | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohanna Daily, MD
Montefiore Medical Center
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 16 / 20 |
| serious Total, serious adverse events | 6 / 20 |
Outcome results
None listed