Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

This study is a prospective, multicenter, observational investigation designed to assess the utility of Remote ThermoVisual Monitoring (RTVM) using the OneStep Foot Scanner™ in detecting diabetic foot ulcers (DFUs) at an earlier stage in high-risk populations. DFUs represent a significant clinical and economic burden, often leading to severe complications, including infections and amputations. Early detection and intervention are critical to reducing morbidity and improving patient outcomes.

The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation in participants using RTVM to a matched historical control group. The secondary objectives include ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints include assessing neuropathy-specific quality of life and evaluating the economic impact of RTVM on DFU and amputation care costs.

The study will enroll approximately 100 participants aged 18 years or older with a confirmed diagnosis of type 1 or type 2 diabetes mellitus and a history of plantar DFUs that have healed within the past five years. Eligible participants will be recruited across up to 30 SerenaGroup® clinical sites. Participants will use the OneStep Foot Scanner™ daily to capture thermographic and visual data of the soles of their feet, which will be analyzed to identify signs of inflammation, potential ulceration, or other abnormalities. The data collected will be reviewed periodically by healthcare professionals for signs requiring intervention.

Participants will be followed for a period of 12 months, during which they will undergo regular clinical evaluations and remote monitoring assessments. The study will not only evaluate the effectiveness of RTVM in reducing the severity of DFUs but also explore its impact on healthcare costs, quality of life, and overall disease management strategies.

This study aims to provide critical insights into the feasibility of implementing RTVM as a preventive tool in routine diabetic foot care and its potential role in mitigating the global burden of DFUs.

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.