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CARE-D-Foot-Nav for Diabetic Foot Ulcers

This study is testing a program called CARE-D-Foot-Nav, which uses a diabetes educator as a dedicated patient navigator. This navigator will help people with diabetic foot ulcers (DFUs) manage their care, including blood sugar control, wound care, and infection treatment. The study wants to see if CARE-D-Foot-Nav helps wounds heal better over 20 weeks compared to standard care. You can join if you are an adult with diabetes who has a full-thickness DFU or has had a single toe amputation. The study is currently unclear about its recruitment status and plans to enroll 270 participants.

Study design
This is an interventional study that will randomize 270 participants to either receive standard care or participate in the CARE-D-Foot-Nav program.
What's involved
If you are in the CARE-D-Foot-Nav group, you will receive weekly support from a patient navigator for 20 weeks after leaving the hospital.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 20 weeks to assess wound healing.

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NCT07223268

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Recruiting
NAAges 18+InterventionalTreatment
Emory University
~270 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:CARE-D-Foot-NavStandard of care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound
Measured over Baseline, Week 20 (day 140 +/- 7 days)

Conditions

Diabetic Foot Ulcer

Explore related trials

Diabetic foot ulcer

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Marcos Schechter, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Marcos Schechter, MD
[email protected]
404-251-8713
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults with diabetes admitted for any reason who have a full-thickness DFU (defined as a wound below the ankle through the dermis) or undergo a single toe amputation
History of prior amputations and DFUs of any severity

Exclusion

Adults unable to understand the nature and scope of the study, enrolled in another clinical trial, or planned for discharge to an acute or long-term care facility,
Patients who undergo amputation of two or more toes during hospitalization and/or have a Society for Vascular Surgery Wound, Ischemia, foot Infection grade 4

What this trial measures

  • Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the woundBaseline, Week 20 (day 140 +/- 7 days)

    Pictures will be taken at baseline and week 20 and compared by two different reviewers. The number of participants with complete wound healing will be reported.