Comprehensive assistance and navigation for diabetic foot ulcers
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
This program tests whether weekly support from a patient navigator helps people hospitalized with diabetic foot ulcers heal their wounds within 20 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07223268 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 270 adults hospitalized with full‑thickness diabetic foot ulcers and randomize them to either usual care or the CARE-D-Foot-Nav intervention for 20 weeks after discharge. The intervention pairs participants with a certified diabetes educator who provides weekly personalized care coordination, diabetes education, transportation help, and connections to medical and social resources. The main outcome is wound healing at 20 weeks, and the study also uses mixed methods to measure program fidelity and acceptability and will perform a cost-effectiveness analysis. The program aims to address social determinants of health that hinder access to multidisciplinary DFU care, particularly in underserved populations.
Who should consider this trial
Good fit: Adults with diabetes who are hospitalized at the study site and have a full‑thickness diabetic foot ulcer or have undergone a single toe amputation, who can consent and plan to be discharged home, are ideal candidates.
Not a fit: Patients who undergo amputation of two or more toes, have severe foot infection/ischemia (SVS grade 4), are being discharged to acute or long‑term care facilities, cannot consent, or are enrolled in another clinical trial are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could increase wound healing rates, reduce amputations, and improve access to coordinated care for underserved patients with diabetic foot ulcers.
How similar studies have performed: Patient navigators have improved outcomes in other chronic diseases, but randomized trials of navigation for diabetic foot ulcers have not previously been done.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia
- Grady Memorial Hospital — Atlanta, Georgia, United States (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.