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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK133557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system. The investigators will enroll 25 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland.
The RCT is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.
The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients in the RCT to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed. | |
| Remote wound monitoring technology | Experimental | Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). |
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| Feasibility Arm | Other | Part A Feasibility Phase: Remote Wound Monitoring Technology -- Patients with an active DFU are asked to capture weekly wound scans over an 8-week study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote wound monitoring technology | Other | Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A Feasibility - Number of Participants With Wound Scan Completion | Participants were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. | 8 weeks |
| Participants Who Successfully Complete Weekly Wound Scan | Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caitlin Hicks, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40857414 | Derived | Wu YHA, Keegan AC, White MPS, Bose S, Leung SG, Sherman R, Abularrage CJ, Selvin E, Hicks CW. AI-Powered Remote Monitoring for Lower Extremity Wound Management: A Randomized Controlled Trial Protocol. JVS Vasc Insights. 2025 Aug 8:100279. doi: 10.1016/j.jvsvi.2025.100279. Online ahead of print. |
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Caregivers were not enrolled in the study, however were trained alongside the enrolled participants on how to use the app for scanning.
Patients with an active diabetic foot ulcer (DFU) were recruited at the Johns Hopkins Hospital multidisciplinary diabetic limb preservation clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Feasibility Phase | Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. |
| FG001 | RCT: Standard Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2023 |
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Feasibility Phase: Patients were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.
RCT: Patients will be computer randomized 1:1 to receive wound care monitoring using remote diabetic foot ulcer (DFU) monitoring technology or standard in-person monitoring for 12 weeks
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Participants received standard in-person monitoring and follow-up in clinic on a biweekly basis for a wound check and care plan update as needed (week 2, 4, 6, 8, 10, 12).
| FG002 | RCT: Remote Wound Monitoring Technology | Participants received Remote wound monitoring technology and in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments were electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up occurred monthly (at the time of enrollment, week 4, week 8, and week 12). |
| COMPLETED |
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| NOT COMPLETED |
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Number of participants in each arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Feasibility | Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. |
| BG001 | Standard Care | Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed. |
| BG002 | Remote Wound Monitoring Technology | Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). Remote wound monitoring technology: Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, Continuous variable measured in years | Age of participants | Mean | Standard Deviation | years |
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| Sex: Female, Male | Sex: Female or Male dichotomous | Sex of participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Race (American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, White, More than one race, Unknown or Not Reported) | Race of participants | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity (Hispanic or Latino, Not Hispanic or Latino, Unknown or Not Reported) | Ethnicity (Hispanic or Latino, Not Hispanic or Latino, Unknown or Not Reported) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A Feasibility - Number of Participants With Wound Scan Completion | Participants were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. | Posted | Count of Participants | Participants | 8 weeks |
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| Primary | Participants Who Successfully Complete Weekly Wound Scan | Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan | Only those participants randomized to the Remote Wound Monitoring Technology arm were included in the overall analysis of weekly scan rates | Posted | Count of Participants | Participants | 12 weeks |
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Up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Feasibility Phase | Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Standard Care | Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed. | 1 | 62 | 20 | 62 | 32 | 62 |
| EG002 | Remote Wound Monitoring Technology | Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). Remote wound monitoring technology: Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely. | 1 | 61 | 15 | 61 | 22 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound care requiring debridement | Surgical and medical procedures | Systematic Assessment |
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Data collection for the standard-care comparison group did not include comprehensive longitudinal wound tracking. The remote monitoring app was available only in English, which limited participation among non-English speakers. Technical barriers affected some participants who required loaner devices to access the app; loaner phones were provided when needed. The study duration was insufficient to evaluate longer-term outcomes such as major limb amputation, and a formal cost-effectiveness analys
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caitlin W. Hicks MD | Johns Hopkins University | 410-955-5165 | chicks11@jhmi.edu |
| Apr 23, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D018409 | Foot Injuries |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| 25-49% scan rate |
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| 0-24% scan rate |
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