Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT06054659
Eligibility Criteria:
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 technology independent of the study following discharge
* Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06054659
Study Brief:
Protocol Section:
NCT06054659