Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Emory University

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Other: Standard of care; Other: CARE-D-Foot-Nav

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07223268

1R01DK139326-01A1 (U.S. NIH Grant/Contract)

STUDY00008140

Details and patient eligibility

About

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)

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Following discharge, the team will conduct research retention phone calls at 4, 8, 12, 16, and 20 weeks to review resource utilization over the past month. Participants will have access to hospital and community resources available to all patients treated within the healthcare system. Other resources may include, but are not limited to, social worker assistance with transportation, diabetes education (with referral by medical provider), nutritional support through Grady's "Food as Medicine Program", and interpreter services

Treatment:

Other: Standard of care

CARE-D-Foot-Nav

Experimental group

Description:

Participants in this arm will be assigned a dedicated DFU patient navigator The navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Participants can call the navigator with DFU-related concerns during the navigator's working hours.

Treatment:

Other: CARE-D-Foot-Nav