Status:
TERMINATED
Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
Lead Sponsor:
Bluedrop Medical Limited
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 norm...
Detailed Description
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 organi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06053047
Start Date
January 22 2024
End Date
September 18 2024
Last Update
October 17 2024
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701