Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT07223268
• Lead Sponsor: Emory University

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)

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.

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-07
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-29
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31
• Primary Completion: 2030-08
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with confirmed wound healing	Baseline, week 22	Researchers will measure the effectiveness of the intervention based on wound healing. Photographs of the wounds will be taken at enrollment and again at week 22 (i.e., approximately two weeks ±7 days after the participant's primary outcome visit). Two independent reviewers, who are clinical DFU experts, will evaluate the photographs to determine whether wound healing has occurred.; If more than one DFU is present, the assessment will be based on the largest wound. If a participant undergoes an amputation or dies before week 20, the ulcer will be classified as not healed.
DFU care clinic attendance	Within 14 and 30 days post hospital discharge	This will be defined as attending outpatient visits with any provider managing a) diabetes b) wound care c) antibiotic for DFU infection, if applicable, and (d) obtaining non-invasive PAD testing if not done in the last 12 months.
Wound area reduction	Baseline, Week 20	Difference in diabetic foot ulcer area will be reported
Major amputation	Baseline, Week 20	Number of subjects undergoing amputation above the ankle.
Number of deaths	Baseline, Week 20	Number of deaths during the study period.
EuroQol five-dimensional (EQ-5D) score	Baseline, Week 20	The EuroQol 5-Dimension (EQ-5D) is a standardized instrument used to measure health-related quality of life. It's a self-report questionnaire that assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a few levels of severity, allowing individuals to describe their health state. Each dimension has five levels: 1 = no problems, to 5 = extreme problems/unable to do. The five answers produce a unique 5-digit health state, for example, 11234, that describes the young person's health state. For example, the code 11234 describes a health state where there are no problems with walking about (mobility) or looking after myself, a little bit of a problem with doing usual activities, some pain or discomfort, and feeling really worried, sad, or unhappy.
Glycemic control: Change in HbA1c	Baseline, Week 20	Change in hemoglobin A1c will be reported.
Perceived social support: Interpersonal Support Evaluation List-12	Baseline, Week 20	The Interpersonal Support Evaluation List-12 (ISEL-12) is a brief, validated questionnaire designed to assess perceived availability of social support. The ISEL-12 includes 12 items and evaluates perceived support across three dimensions: Appraisal Support, Belonging Support and Tangible Support.; Each item is rated on a 4-point Likert scale. Scores range from 12 to 48, with higher scores indicating greater perceived social support and low scores indicating lower social support.
Medical mistrust: Change in the Trust in Physicians Scale	Baseline, Week 20	Trust in Physicians Scale is used to measure interpersonal trust a patient has in their individual physician.; Each item is rated on a 5-point Likert scale. Total score range: 11 (low trust) to 55 (high trust).; Higher scores indicate greater trust in the physician.
Tobacco cessation	Baseline, Week 20	Self-reported cessation at week 20 among those reporting tobacco use at baseline
Acute care utilization	After hospital discharge (up to 20 weeks)	All-cause emergency department (ED) visits and re-hospitalizations
Services accessed	Baseline, Week 20	Services accessed between baseline and week 20 (e.g., foodbank) ascertained through electronic medical record review and participant interviews
Peer support group attendance	Baseline, Week 20	Proportion of CARE-D-Foot-Nav participants who attended ≥1 peer support group meeting and the number of meetings attended
Diabetic foot ulcer - short form (DFS-SF) score	Baseline, 20 weeks	A short form of the Diabetic Foot Ulcer Scale (DFS), which is called the Diabetic Foot Ulcer Scale-Short Form (DFS-SF). It's a 29-item questionnaire designed to assess the impact of diabetic foot ulcers on a patient's quality of life (QOL), grouped into six subscales: leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, and bothered by ulcer care. Each item is scored on a 5-point Likert scale, ranging from 1 = "not at all" to 5 = "very common". Each subscale is scored on a scale of 0 to 100. Higher scores on the DFS-SF indicate a better quality of life, while lower scores indicate a poorer quality of life.; The minimum score for each subscale is 0, representing the worst QOL, and the maximum score is 100, representing the best QOL.
Patient Health Questionnaire-2 (PHQ-2)	Baseline, 20 weeks	The PHQ-2 is a two-question screening for depression that asks about the frequency of a depressed mood and lack of pleasure in activities over the past two weeks. Scores range from 0 to 6, with a score of 3 or higher indicating a positive screen that warrants further assessment, typically with the full PHQ-9, to confirm a diagnosis and gauge severity.
Patient Health Questionnaire-9 (PHQ-9)	Baseline, 20 weeks	The PHQ-9 is a screening tool for depression that uses nine questions answered on a 0-3 scale (not at all, several days, more than half the days, nearly every day), with the total score ranging from 0 to 27. A professional assesses the total score to gauge depression severity: 0-4 (minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20+ (severe).
Food insecurity	Baseline, Week 20	Food insecurity will be assessed via validated EHR-embedded survey items. Food insecurity severity is often evaluated based on the number of affirmative responses to specific questions. More affirmative responses typically indicate greater food insecurity.
Housing stability	Baseline, Week 20	Housing Stability will be assessed using survey items embedded in the electronic health record (EHR). Responses are coded as: 0 = Stable housing (e.g., own/rent a steady place to live); 1 = Unstable housing (e.g., temporarily staying with others, in a shelter, or without a place to live) Scores will be summarized as the proportion of participants with unstable housing at baseline and week 20.
Financial resource strain questionnaire	Baseline, Week 20	Financial resource strain scoring assesses the level of difficulty individuals experience in meeting their basic living expenses and financial obligations, assessed via validated EHR-embedded survey items. A score of 27 on the Financial Strain Questionnaire indicates greater financial strain than a score of 9. Lower scores/categories indicate less financial strain. Higher scores indicate greater strain.
Transportation needs	Baseline, Week 20	Transportation needs will be assessed via a validated EHR-embedded transportation survey from the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) tool.; The transportation tool is a 2-question survey where "yes" indicates transportation needs. More affirmative responses typically indicate increased transportation needs.

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States