Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration (MASTER)
Diabetic Foot
About this trial
This is an interventional prevention trial for Diabetic Foot focused on measuring Diabetic Foot Ulcer (DFU), Remote monitoring, Telemedicine
Eligibility Criteria
Inclusion Criteria: Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing consent prior to any study-specific procedures. Male or female patients 18 years or older. Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit. History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening. Confirmation of presence of peripheral neuropathy with loss of protective sensation (documented in medical records or certain ICD-10 codes for care of patients with diabetes and loss of protective sensation) Patient has signed up for and provided or will provide consent to review of medical records available via the Pluto platform. Access to internet service at the site of device use or willing to use a 4G router provided by the Sponsor Access to cell phone on which they can receive study communications Has a healthcare provider who is confirmed to be their point of contact for foot care or injuries and this HCP uses an EHR that is compatible with Pluto English speaking Exclusion Criteria: Patients with active foot ulcers or other open foot lesions Weight, when fully clothed, of greater than 150 kg Active Charcot arthropathy defined as the phase where the foot is undergoing collapse Active foot infection or gangrene Any history of major or minor lower limb amputation of more than 3 toes. NOTE: the hallux toe must be present on both feet to be eligible Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicates adequate perfusion and qualifies for the study End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renal replacement therapy) Known pregnancy at the time of enrollment.* Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, the patient is unreliable as a study participant Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days. Unable to identify and/or return to a usual care provider for foot care for the duration of the study Unable or unwilling to be enrolled in the Pluto unified medical records system 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. Participants who become pregnant during the study will not be removed. Pregnancy will be noted in their mobile application profile and their participation in the study will be closely monitored.
Sites / Locations
- Duke Clinical Research Institute
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Use of Bluedrop Monitoring Service
Standard of care
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.
Participants continue with routine foot care as recommended by their doctor