Frontlight ResearchEarly access
CompletedNo phase
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Key facts
- Who runs it
- Montefiore Medical Center
- Where
- The Bronx, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 20 people enrolled
- Started
- 3 Jul 2024
- Ended
- 3 Apr 2025
- Type of study
- Interventional
- Treatments tested
- Podimetrics SmartMat
- Record updated
- 30 April 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Type 1 or Type 2 diabetes mellitus
- Prior treatment of DFU within 24 months
- Subject had at least one outpatient follow up with a provider after treatment for DFU
- No active ulcer at time of enrollment
- Male or female, aged 18-75 yrs
- Presence of Neuropathy
- Ambulatory
- Provision of signed and dated informed consent form
- Stated willingness to adhere with all study procedures and availability to participate for the duration of the study
Who cannot take part
- Prior above-knee amputation (AKA) or below-knee amputation (BKA)
- Active diabetic foot ulcer (DFU)
- Unable to comply with study requirements
Where in United States
- Montefiore Medical CenterThe Bronx, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- High risk Diabetic Foot Ulcer (DFU)Treatment being tested
Podimetrics smart map
Treatment: Podimetrics SmartMat
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 April 2026