Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

NCT06782386 · tracked via the Priya Life Science USA tracker

Sponsor

Bluedrop Medical Limited

Phase

Not applicable

Started

2025-02-05

Last updated

2025-08-15

Condition(s) studied

Diabetic Foot Ulcer (DFU)

Investigational drug(s) / intervention(s)

OneStep Foot Scanner

OneStep Foot Scanner: Daily scans with the OneStep Foot scanner will provide thermal and visual data of the soles of the feet to assist in early identification of risk factors associated with Diabetic Foot Ulcers

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of more severe DFUs presenting — 12 months
Incidence of Wagner grade 2 or higher ulcer at the time of first presentation for patients with a history of DFUs that healed in the previous 5 years.

Trial sites (2)

Facility	City	Region	Status
Three Rivers Wound and Hyperbaric Center	North Port	Florida
SerenaGroup Monroeville	Monroeville	Pennsylvania

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06782386 on ClinicalTrials.gov ↗ ← All trials in the USA