Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
Sponsored by Emory University
About this study
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)
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 improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. Healing requires complex, multidisciplinary care focused on glycemic control, wound management, vascular disease treatment, and infection therapy. However, many patients, especially underserved populations such as non-Hispanic Black and Hispanic individuals, face barriers related to social determinants of health that hinder access t…
Where this study is enrolling
- I'm interested
Grady Memorial Hospital
Atlanta, Georgia
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.