Using a smart foot mat to detect early signs of diabetic foot ulcers
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
This study tests if a smart foot mat can help people with diabetes spot early signs of foot ulcers by monitoring temperature changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT05968924 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a foot mat that detects temperature changes to predict diabetic foot ulcers (DFUs) in patients with diabetes. Participants will use the Podimetrics Smart Mat daily for six months to monitor foot temperature, allowing for early intervention to prevent severe DFUs. The study aims to assess adherence to this FDA-cleared device and its potential to reduce the risk of DFUs and healthcare resource utilization. Participants will receive remote training on how to use the device effectively.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with Type 1 or Type 2 diabetes who have a history of diabetic foot ulcers but no active ulcers at enrollment.
Not a fit: Patients with active diabetic foot ulcers or those who have undergone major amputations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of severe diabetic foot ulcers in at-risk patients.
How similar studies have performed: Previous studies have shown that similar temperature monitoring devices can effectively decrease the risk of severe diabetic foot ulcers.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bronx, New York
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Johanna Daily, MD — Montefiore Medical Center
- Study coordinator: Johanna Daily, MD
- Email: jdaily@montefiore.org
- Phone: 718-678-1176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.