Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07143175

CARE-D-FOOT-Nav Pilot

Led by Emory University · Updated on 2025-08-27

25

Participants Needed

4

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

CARE-D-FOOT-Nav Pilot

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years old) with diabetes admitted to the hospital for any reason who have undergone amputation of two or more toes or parts of the foot related to diabetic foot ulcers
  • English-speaking patients (available patient navigators speak English)
Not Eligible

You will not qualify if you...

  • Unable to understand the nature and scope of the study
  • Currently enrolled in another clinical trial
  • Planned discharge to an acute or long-term care facility
  • Planning to receive outpatient diabetic foot ulcer care outside of Grady

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Actively Recruiting

2

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Not Yet Recruiting

3

Emory University Hospital (EUH)

Atlanta, Georgia, United States, 30322

Not Yet Recruiting

4

Emory Decatur Hospital

Decatur, Georgia, United States, 30033

Not Yet Recruiting

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Research Team

M

Marcos Schechter, MD

CONTACT

M

Maya Fayfman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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