NCT06053047

Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bluedrop Medical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers. All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months. Participants selected to receive the Bluedrop Monitoring System (BMS) will place it in their home and stand on it once a day for 12 months. Participants will also need to answer questions about their general foot health and, if using the system, their experience using the device and monitoring service.

Detailed description

This is a siteless study, which is planned to enroll approximately 200 patients with diabetes mellitus and a foot ulcer which has healed within 2-24 months prior to screening. The study will be organized and conducted via a central coordinating center at the Duke Clinical Research Institute. Potentially eligible patients within the state of North Carolina will be contacted about the study and if willing, will provide consent to participation remotely, including use of the Pluto Health''s unified medical records platform. Participants will not attend study sites, as all study visits will take place virtually and/or by telephone contact from the coordinating center and the primary study outcomes will be ascertained by review of health records via the Pluto system. All enrolled participants will be randomized to use of the Bluedrop Monitoring System (BMS) or not in addition to their otherwise usual care. Participants assigned to use of the Bluedrop Monitoring System (BMS) will be provided the Delta Foot Scanner device with monitoring system and will be instructed in daily device use by Bluedrop personnel. Participants will continue to receive all other usual care during the study period, and the patient's other care may be adjusted as considered clinically appropriate by the usual care provider(s). After study enrollment, study visits will take place at 3, 6, 9 and 12 months. These visits will include participant surveys including assessment of neuropathy-specific quality of life, and review of health records via the Pluto Health platform by the study Principal Investigator (PI) to identify the occurrence of foot injury or ulcer and any associated medical or surgical care.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DEVICE	Bluedrop Monitoring Service (BMS)	Remote use of ThermoVisual monitoring

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2023-09-25
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study