TerminatedNot Applicable

Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

Stopped: Unsustainable recruitment rate - too slow to enroll participants

United States26 participantsStarted 2024-01-22

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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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

Exclusion criteria

What they're measuring

Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)

Timeframe: Up to 12 months

Trial details

NCT IDNCT06053047

SponsorBluedrop Medical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-18

View on ClinicalTrials.gov More Diabetic Foot trials