Status:
RECRUITING
CGM and DFU Healing Post-discharge
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot
Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ul...
Detailed Description
The goals of this study are to compare differences in patients with diabetic foot ulcer (DFU) wound healing using continuous glucose monitor (CGM) and point of care testing (POCT) at 16 weeks post-hos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06054659
Start Date
February 20 2024
End Date
January 1 2026
Last Update
August 28 2025
Active Locations (2)
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1
Grady Health System
Atlanta, Georgia, United States, 30303
2
Emory Decatur Hospital
Decatur, Georgia, United States, 30033