An interventional study of Bluedrop Monitoring Service (BMS) in Diabetic Foot, sponsored by Bluedrop Medical Limited. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Bluedrop Medical Limited · Not applicable, Interventional, and Prevention
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.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Bluedrop Medical Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other issue that, at the discretion of the PI, renders the participant ineligible for participation. This includes inability to use the BMS for at least 3 days per week.
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)
Participants continue with routine foot care as recommended by their doctor
Remote use of ThermoVisual monitoring
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
Improvement in participant-reported neuropathy-specific quality of life measures
Survey-ascertained (improvement, better overall score) participant-reported neuropathy-specific quality of life measures
Time frame: Up to 12 months
Healthcare Provider acceptance of Bluedrop Monitoring System (BMS)
Survey-ascertained healthcare provider acceptance of Bluedrop Monitoring System (BMS) in the management of patients with prior Diabetic Foot Ulcer (DFU)
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.