Monitoring Foot Temperature to Predict Diabetic Foot Ulcers Using the FeetSee Thermal Imaging Device in Adults with Diabetes and Peripheral Neuropathy

What this Trial Is About

Diabetic foot ulcers DFUs are a serious health concern for people with diabetes, often developing without pain due to nerve damage, which can lead to severe complications. This study is observing adults with type 1 or type 2 diabetes who have a history of plantar DFUs that have healed for at least six weeks and have diabetic peripheral neuropathy. The research aims to collect foot temperature data over time to improve detection of inflammation that may predict new ulcers, using a device called FeetSee. Participants will receive the FeetSee system, which includes a thermal camera connected to their smartphone or tablet, a stand, and a mobile app. They will be trained to take daily thermal and optical images of the bottom of both feet at home for six to nine months or until a new ulcer appears. These images are securely uploaded to cloud storage where an algorithm analyzes temperature differences to spot potential risk areas. Participants continue their regular foot care throughout the study. During the study, participants will be supported with training and regular technical assistance. Researchers will monitor adherence through device usage logs and collect safety data. They will assess the devices ability to predict new DFUs, evaluate user acceptance and feasibility through questionnaires, and analyze the temperature data alongside clinical outcomes. The study lasts up to nine months per participant, focusing on capturing early signs of foot inflammation to prevent ulceration.

FeetSee Thermal Images Collection Protocol in Diabetes Patients