Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07143175
NA

CARE-D-FOOT-Nav Pilot

Sponsor: Emory University

View on ClinicalTrials.gov

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.

Official title: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-08-05

Completion Date

2027-07

Last Updated

2025-08-27

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (4)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital (EUH)

Atlanta, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States