A randomized controlled trial of patient navigators for post-hospital discharge diabetic foot ulcer care: the Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav) study protocol

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Background: Diabetic foot ulcers (DFUs) are a leading cause of limb loss globally, and DFU-related amputation rates are increasing in the United States. Multidisciplinary care improves DFU healing and prevents amputations. This strategy encompasses 4 key pillars: optimizing glycemic control, managing wounds, treating vascular disease, and addressing infections. However, the implementation of these pillars is fraught with fragmented and delayed care impeding effective wound healing and leading to amputations. Patient navigation improves chronic disease outcomes, including diabetes, but have not been tested for DFU care. Methods/Design: The Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav) is a multicomponent patient navigator program tailored to address individual and structural obstacles to would healing. Adults hospitalized with a DFU (n=270) will be randomized 1:1 to receive the CARE-D-Foot-Nav intervention or usual care. The primary outcome is complete DFU healing at 20-weeks post-hospital discharge adjudicated by independent reviewers blinded to treatment assignment. Secondary outcomes include patient-reported measures and economic outcomes. Discussion: CARE-D-Foot-Nav is the first randomized controlled trial to evaluate patient navigation for DFU care. If the patient navigator program improves outcomes, it could transform care delivery for people with DFUs and reduce preventable limb loss. Trial registration: ClinicalTrials.gov NCT07223268.

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