Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 148 people enrolled
- Started
- 1 Jul 2022
- Ended
- 30 Jun 2024
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Remote wound monitoring technology
- Record updated
- 2 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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 take part
- 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 less than 1 dressing change per week
- Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
Where in United States
- Johns Hopkins University School Of MedicineBaltimore, United States
About the trial
What the trial wants to find out
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 full original descriptionShow less
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 3 groups in the trial
- Standard careNo study treatment, for comparison
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 technologyTreatment being tested
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).
- Feasibility ArmOther group
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.
Treatment: Remote wound monitoring technology
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application
- Record updated
- 2 July 2026