Status:
RECRUITING
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing. The study ...
Detailed Description
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can impr...
Eligibility Criteria
Inclusion
- Adults with diabetes admitted for any reason who have a full-thickness DFU (defined as a wound below the ankle through the dermis) or undergo a single toe amputation
- History of prior amputations and DFUs of any severity
Exclusion
- Adults unable to understand the nature and scope of the study, enrolled in another clinical trial, or planned for discharge to an acute or long-term care facility,
- Patients who undergo amputation of two or more toes during hospitalization and/or have a Society for Vascular Surgery Wound, Ischemia, foot Infection grade 4
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07223268
Start Date
October 7 2025
End Date
August 1 2030
Last Update
October 31 2025
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303