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Recruiting NCT07223268

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Trial Parameters

Condition Diabetic Foot Ulcer
Sponsor Emory University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 270
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-07
Completion 2030-08
Interventions
CARE-D-Foot-NavStandard of care

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 will further: * Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods * Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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