Recruiting

CARE-D-Foot-Nav

Sponsor:

Emory University

Code:

NCT07143175

Conditions

Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Study Details

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.

Conditions

Diabetic Foot Ulcer (DFU)

Study ID

NCT07143175

Start date

Aug 5, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Participants will be assigned a dedicated DFU patient navigator.

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.

Primary outcome measure

  • Proportion of the program components addressed [ Time Frame: Up to 20 weeks during program participation ]
  • Acceptability of the CARE-D-Foot-Nav intervention [ Time Frame: Up to 20 weeks during program participation ]

Central Contacts and Locations

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

More Information

Sponsor

Emory University

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Assistance for Effective Diabetic Foot Navigation
  • Navigators
  • Wound care
  • Wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-02.