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CARE-D-FOOT-Nav Pilot
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (other)
Sponsor: Emory University · Participants: 25 · Started: Aug 5, 2025
Contact the study team
- Marcos Schechter, MD · Phone: 404-251-8713
- Maya Fayfman, MD · Phone: 404-778-1664
Official record on ClinicalTrials.gov — NCT07143175
Locations in the U.S.
| Georgia | Emory University Hospital (EUH), Atlanta (Not yet recruiting) Emory University Hospital Midtown, Atlanta (Not yet recruiting) Grady Memorial Hospital, Atlanta Emory Decatur Hospital, Decatur (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.