Using Continuous Glucose Monitoring to Improve Healing of Diabetic Foot Ulcers

A Randomized Controlled Open-label Study Comparing the Use of Real-time Continuous Glucose Monitoring (Rt-CGM) to Point of Care Testing (POCT) for Glycemic Monitoring in Patients Post-hospitalization for Diabetic Foot Ulcers.

This study is testing if using continuous glucose monitoring can help people with type 2 diabetes and foot ulcers heal better than just regular blood sugar checks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06054659 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Continuous Glucose Monitoring (CGM) compared to standard fingerstick blood glucose testing in patients with type 2 diabetes and diabetic foot ulcers. Participants will be randomly assigned to either the CGM group, where they can monitor their glucose levels in real-time, or the point-of-care testing group, where they will receive standard care without visible glucose data. The study will track wound healing progress over 16 weeks post-hospital discharge, with regular follow-up visits for monitoring and education. The goal is to determine if CGM can enhance glycemic control and improve healing outcomes for diabetic foot ulcers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with type 2 diabetes and diabetic foot ulcers, particularly those with an HbA1c of 8.0% or higher.

Not a fit: Patients with type 1 diabetes or those with very high-risk diabetic foot ulcers that are unlikely to heal may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve wound healing and quality of life for patients with diabetic foot ulcers.

How similar studies have performed: Other studies have shown promising results with CGM in managing diabetes, suggesting potential benefits for wound healing, although this specific application is less explored.

Eligibility criteria

Inclusion Criteria:

* Adults aged 18 and over with type 2 diabetes admitted to general medical and surgical services 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 debridement
* 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 (major or minor) in the limb with a DFU during hospitalization
* Patients with type 1 diabetes
* 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

Where this trial is running

Atlanta, Georgia

• Grady Health System — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Maya Fayfman, MD — Emory University
• Study coordinator: Maya Fayfman, MD

Conditions: Diabetic Foot, Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown, Continuous Glucose Monitoring system, Time in Range, Fingerstick blood glucose testing, Wound healing, Real time - Continuous glucose monitoring