Diabetic FootNCT05579743
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
A study testing Remote wound monitoring technology in people with Diabetic Foot and Diabetic Foot Ulcer, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot
- What is being tested?
- Remote wound monitoring technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 18 years old
- In treatment for lower extremity wound related to diabetic foot ulcer
- Able and willing to use a smartphone to assess the wound for the duration of the study
- English language proficiency
Who cannot join
- Patients with less than 1 dressing change per week
- Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
- Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg, Wound Heal, Diabetes Complications
- Being tested
- Remote wound monitoring technology
- Medical subject headings
- Diabetic Foot, Foot Injuries, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote wound monitoring technologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Remote wound monitoring technology |
| 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. Receives: Other: Remote wound monitoring technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jul 2022
- Primary completion1 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin Hicks, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579743
- Sponsor's protocol ID
- IRB00292929
- Other IDs
- R03DK133557
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40857414
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application
- ClinicalTrials.gov ID
- NCT05579743
- Acronym / sponsor ID
- IRB00292929
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg, Wound Heal, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Remote wound monitoring technologyEnrolled 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). |
| Feasibility Arm | Other | Other: Remote wound monitoring technologyPart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged ≥ 18 years old
- In treatment for lower extremity wound related to diabetic foot ulcer
- Able and willing to use a smartphone to assess the wound for the duration of the study
- English language proficiency
Key exclusion criteria (3 listed)
- Patients with less than 1 dressing change per week
- Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
- Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote wound monitoring technologyHealthy.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. | Other | Feasibility Arm, Remote wound monitoring technology |
Primary outcome
Part A Feasibility - Number of Participants With Wound Scan Completion
Time frame: 8 weeks
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.
Participants Who Successfully Complete Weekly Wound Scan
Time frame: 12 weeks
Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40857414Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin Hicks, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote wound monitoring technology in people with Diabetic Foot and Diabetic Foot Ulcer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A Feasibility - Number of Participants With Wound Scan Completion (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.