CARE-D-Foot-Nav for Foot Ulcer

Recruiting at 3 trial locations

Overseen By Maya Fayfman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Other trial, Facility discharge, others

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

Compensation: Varies

Number of Visits: 2

Duration: 20 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation. It aims to assist people with diabetes who have had part of their foot amputated due to non-healing wounds. The program focuses on a support system where a diabetes educator, dietitian, or medical assistant guides patients through care options and provides resources like transportation and wound supplies. The program seeks to improve access to care and potentially reduce the need for future amputations. It is suitable for English-speaking adults with diabetes who have recently had a significant foot amputation and are receiving care at Grady. As an unphased trial, this study offers a unique opportunity to access comprehensive support and resources that could significantly enhance quality of life.

Do I have to stop taking 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 healthcare provider.

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

Research has shown that patient navigators can help individuals with diabetic foot ulcers receive better care. These navigators train to assist patients in understanding their treatment and healthcare options. By ensuring access to necessary resources, such as transportation and wound care supplies, they may improve the healing of foot ulcers and overall diabetes management.

Specific data on side effects or safety issues for this navigation program is unavailable because it primarily involves support and guidance, not a new drug or medical device. This trial phase focuses on observing the program's effectiveness and patient response, with no expected negative effects, as navigators provide non-invasive support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE-D-Foot-Nav because it introduces a dedicated diabetic foot ulcer (DFU) patient navigator, which is a fresh approach compared to the standard treatments like wound care and offloading. Unlike traditional methods that focus on the physical aspects of ulcer management, this treatment emphasizes personalized guidance and support, helping patients better navigate their care journey. The hope is that by improving patient engagement and adherence through tailored assistance, outcomes for people with diabetic foot ulcers will significantly improve.

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

Research has shown that programs with patient navigators have improved diabetes care by facilitating access to necessary treatments. However, the effectiveness of these programs for diabetic foot ulcers (DFUs) is still under investigation. Approximately one-third of people with diabetes may develop a foot ulcer, potentially leading to serious complications like amputations. In this trial, participants in the intervention group will receive a dedicated DFU patient navigator as part of the CARE-D-Foot-Nav program. This program aims to guide patients through the healthcare system, potentially enhancing treatment and healing. Although full evidence of its impact on DFUs is not yet available, the program appears promising due to its focus on providing coordinated and accessible care. ^{1 2 3 5 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 people living with diabetes in the U.S. who are at risk of developing foot ulcers or want to prevent them. Participants will work closely with a dedicated navigator to manage their condition over a 20-week program, which includes regular check-ins and personalized resources.

Inclusion Criteria

I speak English.

I am an adult with diabetes and have had an amputation of 2 or more digits due to a diabetic foot ulcer.

Exclusion Criteria

I understand what participating in this study involves.

Enrolled in another clinical trial

I will be discharged to a care facility after my hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly encounters with a patient navigator for 20 weeks, focusing on DFU care and resource facilitation

20 weeks

At least 1 visit per week (in-person or phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing assessment

2 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Trial Overview The CARE-D-Foot-Nav pilot study is testing a patient navigator intervention designed to help diabetic individuals access multidisciplinary care for preventing and managing foot ulcers. It involves weekly support from healthcare professionals like diabetes educators, dietitians, and medical assistants.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will be assigned a dedicated DFU patient navigator.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223268

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

2. reporter.nih.gov reporter.nih.gov/project-details/11049694

Project Details - NIH RePORTER Informed by extensive preliminary data and community input, we developed the CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot ...

3. 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.

4. trialx.com trialx.com/clinical-trials/listings/325497/comprehensive-assistance-and-resources-for-effective-diabetic-foot-navigation/?&geo_lat=33.6795531&geo_lng=-84.4393724&radius=10&place=East%20Point&user_country=United%20States

Comprehensive Assistance and Resources for Effective ... The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial ...

5. frontiersin.org frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2024.1440209/full

Emerging technologies for the management of diabetic foot ... This paper highlights significant findings in DFU treatments and emerging advanced technologies for monitoring ulceration in patients with diabetes.

6. app.trialscreen.org app.trialscreen.org/trials/comprehensive-assistance-resources-effective-diabetic-foot-navigation-trial-nct07223268

Comprehensive Assistance and Resources for Effective ... Participants in the navigation program may experience better diabetic foot ulcer healing, improved diabetes management, better access to healthcare services, ...