Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav) Pilot Study for Diabetic Foot Ulcer Care

What this Trial Is About

This research aims to evaluate the CARE-D-Foot-Nav program, a patient navigator-led intervention for adults with diabetic foot ulcers (DFUs). DFUs are a serious diabetes complication that often lead to amputations and high healthcare costs in the United States. Despite the need for complex, multidisciplinary care involving glycemic control, wound management, and infection treatment, healing rates remain low, and diabetes-related amputations are increasing. The study focuses on supporting patients in navigating healthcare to improve healing outcomes, particularly for underserved populations. Participants will be assigned a dedicated patient navigator, such as a diabetes educator, registered dietitian, or medical assistant, who will provide weekly 30- to 60-minute sessions by phone or in person over 20 weeks. Navigators help patients access key aspects of DFU care and offer resources tailored to individual needs. Additional support may include transportation assistance and wound care supplies. This is a single-arm pilot study examining the program's implementation, patient engagement, and cost-effectiveness. During the study, participants will have regular contacts with their navigator and undergo various assessments including wound healing status, clinic attendance, hemoglobin A1c levels, quality of life scores, and social support measures at baseline and throughout 20 weeks. Researchers will monitor outcomes such as ulcer healing, amputation rates, mortality, and healthcare use. The study period includes up to 20 weeks of program participation with ongoing evaluation of program components and participant acceptability.

CARE-D-FOOT-Nav Pilot