CGM and DFU Healing Post-discharge (NCT06054659) | Clinical Trial Compass
CompletedNot Applicable
CGM and DFU Healing Post-discharge
United States116 participantsStarted 2024-02-20
Plain-language summary
The purpose of this study is to look at the benefits of using a Continuous Glucose Monitoring (CGM) system compared with standard-of-care testing for patients with type 2 diabetes and diabetic foot ulcers (DFU) and how this will improve wound healing.
The CGM system allows medical staff and patients with diabetes to monitor and make treatment decisions to improve glucose control, without the need for performing fingersticks. Hence, the use of CGM will decrease the painful and burdensome task of performing finger sticks several times per day and may prevent low blood glucose in patients with diabetes.
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:
* Adults aged 18 and over with type 2 diabetes admitted to the hospital with diabetic foot ulceration with or without infection (cellulitis or osteomyelitis)
* HbA1c \>= 8.0% at the time of enrollment
* Treatment of diabetic foot ulcer with medical management and/or a single toe amputation
* Patients with prior amputation at or below the ankle may be enrolled if they develop an ulceration in the foot that is not felt to be a surgical wound from prior amputation, defined as a healed surgical site for at least 6 weeks after the surgery before the onset of the new ulceration
* Wound, Ischemia, foot Infection (WIfI) score of 1-3
* Duration of DFU less than 1 year
* Able and willing to use continuous glucose monitoring technology independently or with the assistance of a close relative or caretaker
Exclusion Criteria:
* Age \< 18 years
* Homelessness or anticipated to have unstable housing after discharge
* A WIfI score of 4, denoting a very high risk for major amputation (above or below the knee) and very low odds of healing within 12 months
* Any amputation more extensive than just a single toe during index hospitalization
* Patients with type 1 diabetes
* Participants enrolled in another interventional clinical trial (including during the run-in period).
* Inability to participate in the informed consent process for any reason
* Female subjects who are pregnant or breastfeeding at the time of enrollment in the study
* Subjects planning to use CGM technolo…
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.