Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration (NCT06053047) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)