CARE-D-FOOT-Nav Pilot

NCT ID: NCT07143175

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2027-07-31

Brief Summary

This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).

Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise.

Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed.

This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.

Detailed Description

The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a pilot 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. DFU healing rates remain low in the US. DFUs that fail to heal within 30 days are at a higher risk. Unfortunately, there is a resurgence in diabetes-related amputations. Healing requires complex, multidisciplinary care, focused on glycemic control, wound management, vascular disease treatment, and infection therapy. A strategy to facilitate multidisciplinary DFU care and support patients in their healing journey that can be widely implemented is essential to improve DFU healing rates and curb the diabetes-related limb loss pandemic, particularly for underserved and high-risk populations.

Patient navigators are healthcare personnel who mitigate barriers to care by facilitating care logistics, connecting patients to available resources, and promoting patient engagement. While navigators have been shown to improve diabetes outcomes, their effectiveness in improving DFU care and promoting healing remains untested. Informed by extensive preliminary data and community input, the investigators developed the CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program.

This study aims to determine whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively.

Conditions

Diabetic Foot Ulcer (DFU)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Participants will be assigned a dedicated DFU patient navigator.

Group Type: EXPERIMENTAL

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Intervention Type: OTHER

The CARE-D-FOOT-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program is a patient navigator intervention that aims to increase access to guideline-concordant multidisciplinary DFU care to improve DFU healing.

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.

Based on community input, navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Additional contact may be warranted to coordinate appointments and transportation. Participants can call the navigator with DFU-related concerns at any time during the navigator's working hours. The overarching goal of the navigator is to help patients access the four key pillars of DFU care, thereby optimizing the chances of DFU healing.

Interventions

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

The CARE-D-FOOT-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program is a patient navigator intervention that aims to increase access to guideline-concordant multidisciplinary DFU care to improve DFU healing.

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.

Based on community input, navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Additional contact may be warranted to coordinate appointments and transportation. Participants can call the navigator with DFU-related concerns at any time during the navigator's working hours. The overarching goal of the navigator is to help patients access the four key pillars of DFU care, thereby optimizing the chances of DFU healing.

Intervention Type: OTHER

Other Intervention Names

CARE-D-Foot-Nav; Diabetic Foot Navigator

Eligibility Criteria

Inclusion Criteria

• Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations)
• English-speaking patients (available patient navigators are English-speaking).

Exclusion Criteria

• Patients who are unable to understand the nature and scope of the study,
• Enrolled in another clinical trial,
• Planned discharge to an acute or long-term care facility,
• Planning to receive outpatient DFU care outside of Grady.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Marcos C. Schechter

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcos Schechter, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Emory University Hospital (EUH)

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Emory Decatur Hospital

Decatur, Georgia, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Marcos Schechter, MD

Role: CONTACT

marcos.coutinho.schechter@emory.edu

404-251-8713

Maya Fayfman, MD

Role: CONTACT

maya.fayfman@emory.edu

404-778-1664

Other Identifiers

STUDY00008869

Identifier Type: -

Identifier Source: org_study_id