Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

Stopped early · Not applicable

Conditions studied: Diabetic Foot

In brief

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.

Key facts

Study ID

NCT06053047

Run by

Bluedrop Medical Limited

People needed

26

Starts

2024-01-22

Expected to finish

2024-09-18

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke Clinical Research Institute — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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