Monitoring foot temperature and visuals to manage diabetic foot ulcers

A Prospective Observational Study Evaluating the Effectiveness of Photographic and Thermal Monitoring in the Management of High-risk Diabetic Foot Patients

This study is testing if a new foot scanning device can help catch early signs of serious foot ulcers in people with diabetes to prevent them from getting worse.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bluedrop Medical Limited (industry)
• Locations: 2 sites (North Port, Florida and 1 other locations)
• Trial ID: NCT06782386 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Remote ThermoVisual Monitoring (RTVM) using the OneStep Foot Scanner™ to detect diabetic foot ulcers (DFUs) early in high-risk patients. It compares the incidence of Wagner stage 2 or higher DFUs in participants using RTVM to a matched control group from a retrospective database. The study aims to enroll approximately 100 adults with type 1 or type 2 diabetes and a history of plantar DFUs that healed within the past five years across up to 30 clinical sites. Participants will use the device daily to capture temperature and visual data of their feet, which will be analyzed for signs of inflammation or anomalies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with type 1 or type 2 diabetes and a history of plantar DFUs that have healed within the last five years.

Not a fit: Patients with active foot infections, critical limb threatening ischemia, or significant mental health disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection and intervention for diabetic foot ulcers, potentially reducing complications and improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using remote monitoring technologies for early detection of diabetic foot complications, suggesting this approach may be effective.

Eligibility criteria

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.

Where this trial is running

North Port, Florida and 1 other locations

• Three Rivers Wound and Hyperbaric Center — North Port, Florida, United States (RECRUITING)
• SerenaGroup Monroeville — Monroeville, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Thomas Serena — Serena Group
• Study coordinator: Thomas Serena

Conditions: Diabetic Foot Ulcer, DFU, Remote monitoring, Thermovisual monitoring