CARE-D-Foot-Nav for Foot Ulcer

Overseen By Maya Fayfman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cognitive impairment, Other trial, Discharge plan, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to heal diabetic foot ulcers, which are serious wounds on the feet of people with diabetes. The study compares a special program called CARE-D-Foot-Nav, where participants receive help and guidance from a dedicated navigator, to the usual care provided at hospitals. It aims to determine if the navigator program can improve healing over 20 weeks. Individuals with diabetes, a full-thickness foot ulcer, or a history of toe removal might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance healing for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CARE-D-Foot-Nav program is safe?

Research has shown that the CARE-D-Foot-Nav program, which employs patient navigators for diabetic foot ulcer care, is safe and easy to manage. No reports of negative effects have emerged from this type of support. The program emphasizes personal help and guidance, not a new drug or medical procedure, resulting in very low risk. Participants have regular check-ins with a navigator by phone or in person, ensuring safety and comfort throughout the program. This approach focuses on enhancing care and support, not introducing a physically invasive treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic foot ulcers (DFUs) involve wound care, pressure offloading, and managing blood sugar levels. However, CARE-D-Foot-Nav is unique because it introduces a dedicated patient navigator who provides personalized support and guidance. This navigator connects with participants weekly, either by phone or in person, offering tailored advice and addressing concerns in real time. Researchers are excited about this approach because it offers continuous, personalized care, potentially improving patient outcomes by ensuring individuals stay engaged with their treatment plan and address issues promptly.

What evidence suggests that the CARE-D-Foot-Nav intervention is effective for diabetic foot ulcer healing?

Studies have shown that patient navigators can improve diabetes management. This trial specifically examines the effectiveness of the CARE-D-Foot-Nav program for diabetic foot ulcers (DFUs). Participants in the CARE-D-Foot-Nav arm will receive a dedicated navigator to assist in managing their foot ulcers, with the goal of promoting healing through ongoing support and guidance. Although solid data on its success with DFUs is not yet available, the program aims to improve access to care and ensure adherence to treatment plans. Early results suggest it may enhance healing outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Marcos Schechter, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who are at risk of foot ulcers or currently have a foot ulcer. Participants should be willing to follow the study procedures and attend all required visits. Specific details about inclusion and exclusion criteria were not provided.

Inclusion Criteria

I have diabetes and a deep wound below my ankle or have had a toe amputation.

I have had amputations or diabetic foot ulcers before.

Exclusion Criteria

I am not enrolled in another clinical trial and understand this study.

I had two or more toes amputated and/or have a severe foot wound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly support from a certified diabetes educator acting as a patient navigator for 20 weeks

20 weeks

Weekly visits (in-person or phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CARE-D-Foot-Nav

Trial Overview

The CARE-D-Foot-Nav program, which includes specialized patient navigation, is being tested against standard care to see if it improves healing of diabetic foot ulcers over 20 weeks. The study will also assess how well the program is received and its cost-effectiveness.

How Is the Trial Designed?

Group I: CARE-D-Foot-Nav Experimental Treatment 1 Intervention

Participants in this arm will be assigned a dedicated DFU patient navigator The navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Participants can call the navigator with DFU-related concerns during the navigator's working hours.

Group II: Standard of Care Active Control 1 Intervention

Following discharge, the team will conduct research retention phone calls at 4, 8, 12, 16, and 20 weeks to review resource utilization over the past month. Participants will have access to hospital and community resources available to all patients treated within the healthcare system. Other resources may include, but are not limited to, social worker assistance with transportation, diabetes education (with referral by medical provider), nutritional support through Grady's "Food as Medicine Program", and interpreter services

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07143175

Study Details | NCT07143175 | CARE-D-FOOT-Nav Pilot

While navigators have been shown to improve diabetes outcomes, their effectiveness in improving DFU care and promoting healing remains untested.

2.

reporter.nih.gov

reporter.nih.gov/project-details/11049694

Project Details - NIH RePORTER

We will randomize 270 participants hospitalized with a DFU to CARE-D-Foot-Nav versus usual care (1:1 ratio) for 20 weeks post-hospital discharge. To minimize ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07223268

Comprehensive Assistance and Resources for Effective ...

Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound, Pictures will be taken at baseline and week 20 and ...

4.

withpower.com

withpower.com/trial/phase-diabetic-foot-9-2025-1be0f

CARE-D-Foot-Nav for Foot Ulcer

The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, ...

5.

diabetesjournals.org

diabetesjournals.org/care/article/46/1/209/148198/Etiology-Epidemiology-and-Disparities-in-the

Etiology, Epidemiology, and Disparities in the Burden of ...

The lifetime risk of foot ulcer is 19% to 34%, and this number is rising with increased longevity and medical complexity of people with diabetes ...

6.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0294813

Associations between specialty care and improved outcomes ...

Specialty care was associated with longer event-free survivals for patients with diabetic foot ulcers. Increased, equitable access to specialty ...