NCT07223268

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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 to this care. In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources. Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	CARE-D-Foot-Nav	CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator. The navigator will assist the subjects with diabetic foot ulcer care, including: Glycemic control, Wound management, Infection management, and peripheral artery disease (PAD) management. Apart from that, the navigator will also provide tools to improve access to DFU care and emotional support, like: Outpatient care coordination, Transportation assistance, Language-concordant care, Peer support, Support if amputations are recommended, and Spiritual Support. Navigator will also assess the participants and screen for Depression, tobacco use, food insecurity, alcohol use, financial resource strain, and housing instability.
OTHER	Standard of care	Standard of care for DFU.

Timeline

• Start date: 2025-10-07
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-10-31
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States