Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

Running, not enrolling · Not applicable

Conditions studied: Diabetic Foot Ulcer (DFU)

In brief

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.

Key facts

Study ID: NCT06782386
Run by: Bluedrop Medical Limited
People needed: 100
Starts: 2025-02-05
Expected to finish: 2026-08-01
Last updated by the study team: 2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

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

Full record on ClinicalTrials.gov

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