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CARE-D-FOOT-Nav Pilot

RECRUITINGN/ASponsored by Emory University
Actively Recruiting
PhaseN/A
SponsorEmory University
Started2025-08-05
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

Summary

This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav). Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise. Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed. This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations)
* English-speaking patients (available patient navigators are English-speaking).

Exclusion Criteria:

* Patients who are unable to understand the nature and scope of the study,
* Enrolled in another clinical trial,
* Planned discharge to an acute or long-term care facility,
* Planning to receive outpatient DFU care outside of Grady.

Conditions2

DiabetesDiabetic Foot Ulcer (DFU)

Locations4 sites

Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
Emory Decatur Hospital
Decatur, Georgia, 30033

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