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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Remote use of ThermoVisual monitoring
Duke Clinical Research Institute
Durham, North Carolina, United States
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers where a higher score is a worse outcome \<min score of 0 and max score of 3\>) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
Time frame: Up to 12 months
Participant engagement rates in the Bluedrop Monitoring System (BMS)
Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
Time frame: Up to 12 months
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs)
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
Time frame: Up to 12 months
Relative risk reduction in resource utilization
Both all-cause and related to diabetic foot complications, in participants assigned to use of the Bluedrop Monitoring System (BMS) compared to those not assigned to use of the Bluedrop Monitoring System (BMS)
Time frame: Up to 12 months
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PREVENTION
Masking
NONE
Enrollment
26