Comprehensive Diabetic Foot Navigation (CARE-D-Foot-Nav) Pilot
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study
This pilot will test whether a patient navigator program helps hospitalized adults with diabetic foot ulcers who had foot amputations get coordinated care and heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT07143175 on ClinicalTrials.gov |
What this trial studies
CARE-D-Foot-Nav is a pilot interventional program that assigns each participant a dedicated diabetic foot ulcer (DFU) patient navigator (a diabetes educator, registered dietitian, or medical assistant) who provides weekly 30–60 minute phone or in-person contacts over a 20-week period. Navigators help with care logistics, connect patients to resources, and promote engagement with multidisciplinary wound, vascular, infection, and diabetes care teams. The trial enrolls adults with diabetes hospitalized at participating Emory/Grady hospitals who undergo DFU-related amputation of two or more digits and who speak English. Outcomes focus on healing-related metrics and the feasibility of implementing navigator-led support in this high-risk, often underserved population.
Who should consider this trial
Good fit: Adults (≥18 years) with diabetes who are hospitalized at participating Emory/Grady hospitals, underwent a DFU-related amputation of two or more digits, and speak English are the ideal candidates.
Not a fit: Non–English-speaking patients, those discharged to acute or long-term care facilities, patients planning outpatient DFU care outside Grady, or those unable to understand the program are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could improve DFU healing, reduce repeat or higher-level amputations, and increase access to coordinated multidisciplinary care for high-risk patients.
How similar studies have performed: Patient navigator programs have improved some diabetes outcomes in prior work, but navigator-led interventions specifically targeting DFU healing are largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Atlanta, Georgia and 3 other locations
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Not_yet_recruiting)
- Emory University Hospital (EUH) — Atlanta, Georgia, United States (Not_yet_recruiting)
- Emory Decatur Hospital — Decatur, Georgia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Marcos Schechter, MD — Emory University
- Study coordinator: Marcos Schechter, MD
- Email: marcos.coutinho.schechter@emory.edu
- Phone: 404-251-8713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.