NCT07223268 · Emory University
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
What this study is about
The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing.
View original scientific description
The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing.
Interventions
OTHER
CARE-D-Foot-Nav
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, including: Glycemic control, Wound management, Infection management, and peripheral artery disease (PAD) management. Apart from that, the navigator will also provide tools to improve access to DFU care and emotional support, like: Outpatient care coordination, Transportation assistance, Language-concordant care, Peer support, Support if amputations are recommended, and Spiritual Support. Navigator will also assess the participants and screen for Depression, tobacco use, food insecurity, alcohol use, financial resource strain, and housing instability.
OTHER
Standard of care
Standard of care for DFU.
Primary outcome measures
Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Atlanta, Georgia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations