Actively Recruiting
CARE-D-FOOT-Nav Pilot
Led by Emory University · Updated on 2025-08-27
25
Participants Needed
4
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CARE-D-FOOT-Nav Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years old) with diabetes admitted to the hospital for any reason who have undergone amputation of two or more toes or parts of the foot related to diabetic foot ulcers
- English-speaking patients (available patient navigators speak English)
You will not qualify if you...
- Unable to understand the nature and scope of the study
- Currently enrolled in another clinical trial
- Planned discharge to an acute or long-term care facility
- Planning to receive outpatient diabetic foot ulcer care outside of Grady
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
3
Emory University Hospital (EUH)
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
4
Emory Decatur Hospital
Decatur, Georgia, United States, 30033
Not Yet Recruiting
Research Team
M
Marcos Schechter, MD
CONTACT
M
Maya Fayfman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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