Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database. Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies. Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months. Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.

Inclusion Criteria: * Male or female patients 18 years or older * Diagnosis of type 1 or type 2 diabetes mellitus * History of a plantar DFU within 5 years of enrollment. * Access to a phone on which they can receive study communications. * SUBGROUP: a patient with an active Wagner grade 1 DFU may be enrolled if in the opinion of the investigator the wound is sufficiently epithelialized and can withstand the pressure applied during scanning. Exclusion Criteria: * Weight, when fully clothed, of greater than 300 kg (\~330 lbs) NOTE: for participants over 150kg the device will need to be used from a seated position * Active Charcot arthropathy defined as the phase where the foot is undergoing collapse * Active foot infection or gangrene * Critical limb threatening ischemia as evidenced by rest pain, or the presence of gangrene on any part of the foot. * Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, rule the patient is unreliable as a study participant * Any travel plans expected to result in an interruption of device use for greater than 30 consecutive days.