No phaseActive, not recruiting
Remote Temperature and Visual Monitoring To Help 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
- Sponsor
- Bluedrop Medical Limited (Industry)
- Enrolment
- 100 planned
- Conditions
- Diabetic Foot Ulcer (DFU)
- Interventions
- OneStep Foot Scanner
- Ages
- adults, older adults
- Registry
- NCT06782386
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Number of more severe DFUs presenting
History
Primary completion expected
Last registry update
Started
Registered