RECRUITING

CARE-D-FOOT-Nav Pilot

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study

Quick Facts

Study Start:2025-08-05
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07143175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * English-speaking patients (available patient navigators are English-speaking).
  1. * Patients who are unable to understand the nature and scope of the study,
  2. * Enrolled in another clinical trial,
  3. * Planned discharge to an acute or long-term care facility,
  4. * Planning to receive outpatient DFU care outside of Grady.

Contacts and Locations

Study Contact

Marcos Schechter, MD
CONTACT
404-251-8713
marcos.coutinho.schechter@emory.edu
Maya Fayfman, MD
CONTACT
404-778-1664
maya.fayfman@emory.edu

Principal Investigator

Marcos Schechter, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
United States
Emory Decatur Hospital
Decatur, Georgia, 30033
United States

Collaborators and Investigators

Sponsor: Emory University

  • Marcos Schechter, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Assistance for Effective Diabetic Foot Navigation
  • Navigators
  • Wound care
  • Wound healing

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer (DFU)