Trial results for a study investigating the early detection of Diabetic Foot Ulcers (DFU) using novel technology were posted on ClinicalTrials.gov on 2026-04-30. The study observed a median adherence of 6.4 foot scans per week to the monitoring device among high-risk participants.
Background
Diabetic Foot Ulcers are a severe complication of diabetes, often leading to infections, amputations, and significant morbidity. Early detection of risk factors, such as changes in foot temperature, is crucial for preventing ulcer formation and improving patient outcomes. Current management typically involves regular foot checks, specialized footwear, and blood glucose control. Technologies that enable continuous, non-invasive monitoring for early warning signs could potentially revolutionize DFU prevention by allowing timely intervention before an ulcer develops. The Podimetrics Smart Mat, an FDA-cleared device, is designed to detect temperature changes that may predict foot ulceration in patients with diabetes mellitus.
Trial design
This completed study, identified as Phase NA, enrolled 20 participants diagnosed with Diabetic Foot Ulcer. The trial aimed to study the adherence of the participant cohort to a non-significant risk device, the Podimetrics Smart Mat, over a six-month period. The device is a foot mat designed to detect changes in foot temperature that may predict foot ulceration. The study focused on understanding participant engagement with the technology and monitoring health outcomes within this high-risk group.
Key results
The trial results provided several key measurements for the High Risk Diabetic Foot Ulcer (DFU) group:
- The median adherence to the use of the SmartMat was 6.4 number of foot scans/week.
- The number of participants who used health care facilities during the study period was 6 Participants.
- The occurrence of Diabetic Foot Ulcer (DFU) was observed in 5 Participants.
- The median number of re-engagement calls per participant over the 6-month study period was 2 calls per participant.
What this means
The posted results offer insights into the practical implementation of a novel technology for early DFU detection. A median adherence of 6.4 foot scans per week suggests a reasonable level of engagement with the Podimetrics Smart Mat among high-risk individuals. Despite this monitoring, the occurrence of DFU in 5 out of 20 participants highlights the persistent challenge of preventing ulcers in this vulnerable population. The median of 2 re-engagement calls per participant indicates that ongoing support or reminders may be necessary to maintain adherence and maximize the benefits of such monitoring devices. These findings can inform strategies for patient education, support, and the integration of early detection technologies into routine DFU prevention protocols.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05968924, titled "Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology", were posted on 2026-04-30 on clinicaltrials.gov.