CARE-D-FOOT-Nav Pilot

Conditions

• Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation — OTHER
  The CARE-D-FOOT-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program is a patient navigator intervention that aims to increase access to guideline-concordant multidisciplinary DFU care to improve DFU healing. CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator. The navigator will assist the subjects with diabetic foot ulcer care. Based on community input, navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Additional contact may be warranted to coordinate appointments and transportation. Participants can call the navigator with DFU-related concerns at any time during the navigator's working hours. The overarching goal of the navigator is to help patients access the four key pillars of DFU care, thereby optimizing the chances of DFU healing.

Study Details

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.

Key Dates

Start date

Aug 5, 2025

Status verified

Aug 2025

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Intervention Group
  Participants will be assigned a dedicated DFU patient navigator.

Primary Outcome Measure

Proportion of the program components addressed [ Time Frame: Up to 20 weeks during program participation ]

Central Contacts

• Marcos Schechter, MD
  404-251-8713
  [email protected]
• Maya Fayfman, MD
  404-778-1664
  [email protected]

Locations (4)

Find similar trials in Atlanta, GA

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