Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration (MASTER)
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|ClinicalTrials.gov Identifier: NCT06053047|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot||Device: Bluedrop Monitoring Service (BMS)||Not Applicable|
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 BMS or not in addition to their otherwise usual care. Participants assigned to use of the 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 (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs|
|Estimated Study Start Date :||September 2023|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Experimental: Use of Bluedrop Monitoring Service
The BMS is made up of the Delta Foot Scanner (DFS) device, its accompanying Sentinel Review Interface (SRI) software and a Bluedrop virtual monitoring service.
The DFS is intended to be used for 30 seconds, once per day, by a person in their home. It is important that while using the device that the participant continues with their routine foot care as recommended by their doctor.
Device: Bluedrop Monitoring Service (BMS)
Remote use of ThermoVisual monitoring
No Intervention: Standard of care
Participants continue with routine foot care as recommended by their doctor
- Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]Relative risk reduction in the incidence of new DFU (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
- Participant engagement rates in the BMS [ Time Frame: Up to 12 months ]Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
- Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]Relative risk reduction in the severity of new DFU in participants assigned to use of the BMS compared to those not assigned to use of the BMS
- Relative risk reduction in resource utilization [ Time Frame: Up to 12 months ]Both all-cause and related to diabetic foot complications, in participants assigned to use of the BMS compared to those not assigned to use of the BMS
- Improvement in participant-reported neuropathy-specific quality of life measures [ Time Frame: Up to 12 months ]Survey-ascertained (improvement, better overall score) participant-reported neuropathy-specific quality of life measures
- Healthcare Provider acceptance of BMS [ Time Frame: Up to 12 months ]Survey-ascertained healthcare provider acceptance of BMS in the management of patients with prior DFU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053047
|Contact: Stefany Olague||9196680302||smalltrials-CRC@duke.edu|
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27701|
|Contact: Stefany Olage|
|Principal Investigator:||Jennifer Green, MD||Duke UMC|