An interventional study of CARE-D-Foot-Nav and Standard of care in Diabetic Foot Ulcer, sponsored by Emory University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-31.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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:
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 270 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Following discharge, the team will conduct research retention phone calls at 4, 8, 12, 16, and 20 weeks to review resource utilization over the past month. Participants will have access to hospital and community resources available to all patients treated within the healthcare system. Other resources may include, but are not limited to, social worker assistance with transportation, diabetes education (with referral by medical provider), nutritional support through Grady's "Food as Medicine Program", and interpreter services
Other: Standard of care
Participants in this arm will be assigned a dedicated DFU patient navigator The navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Participants can call the navigator with DFU-related concerns during the navigator's working hours.
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.
Standard of care for DFU.
Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound
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.
Time frame: Baseline, Week 20 (day 140 +/- 7 days)
Number of participants with confirmed wound healing
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.
Time frame: Baseline, week 22
DFU care clinic attendance
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.
Time frame: Within 14 and 30 days post hospital discharge
Wound area reduction
Difference in diabetic foot ulcer area will be reported
Time frame: Baseline, Week 20
Major amputation
Number of subjects undergoing amputation above the ankle.
Time frame: Baseline, Week 20
Number of deaths
Number of deaths during the study period.
Time frame: Baseline, Week 20
EuroQol five-dimensional (EQ-5D) score
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.
Time frame: Baseline, Week 20
Glycemic control: Change in HbA1c
Change in hemoglobin A1c will be reported.
Time frame: Baseline, Week 20
Perceived social support: Interpersonal Support Evaluation List-12
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.
Time frame: Baseline, Week 20
Medical mistrust: Change in the Trust in Physicians Scale
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.
Time frame: Baseline, Week 20
Tobacco cessation
Self-reported cessation at week 20 among those reporting tobacco use at baseline
Time frame: Baseline, Week 20
Acute care utilization
All-cause emergency department (ED) visits and re-hospitalizations
Time frame: After hospital discharge (up to 20 weeks)
Services accessed
Services accessed between baseline and week 20 (e.g., foodbank) ascertained through electronic medical record review and participant interviews
Time frame: Baseline, Week 20
Peer support group attendance
Proportion of CARE-D-Foot-Nav participants who attended ≥1 peer support group meeting and the number of meetings attended
Time frame: Baseline, Week 20
Diabetic foot ulcer - short form (DFS-SF) score
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.
Time frame: Baseline, 20 weeks
Patient Health Questionnaire-2 (PHQ-2)
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.
Time frame: Baseline, 20 weeks
Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: Baseline, 20 weeks
Food insecurity
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.
Time frame: Baseline, Week 20
Housing stability
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.
Time frame: Baseline, Week 20
Financial resource strain questionnaire
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.
Time frame: Baseline, Week 20
Transportation needs
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.
Time frame: Baseline, Week 20
Plan to share: Yes — The team will de-identify identifiable data and assign each study participant a unique identifier (ID). The team will use the Safe Harbor method to comply with the HIPAA Privacy Rule. The Safe Harbor method removes all 18 identifiers of Protected Health Information (PHI) from data to ensure that the data cannot be traced back to one person. PI will share the individual-participant level raw data described below through deposition in a controlled-access public repository (Emory Dataverse). To preserve participant anonymity and safety, PI will not share participant interviews or navigator encounter audio recordings. We will redact interview transcripts and encounters to remove any potential identifiers. Foot images will be edited to remove identifying features, including faces. The informed consent forms will reflect these plans.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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