ArticlemedRxiv : the preprint server for health sciences2025
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.
Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07223268 (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
Who cites it
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Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
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.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.