Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT07223268
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2025-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
The study will further:
* Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods
* Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)
The study will further:
* Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods
* Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)
Detailed Description:
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. Healing requires complex, multidisciplinary care focused on glycemic control, wound management, vascular disease treatment, and infection therapy. However, many patients, especially underserved populations such as non-Hispanic Black and Hispanic individuals, face barriers related to social determinants of health that hinder access to this care.
In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01DK139326-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |