Remote monitoring for diabetic foot ulcers
Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application
This study tests whether using a smartphone app to monitor diabetic foot ulcers works as well as regular in-person check-ups for helping patients heal and stay satisfied with their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05579743 on ClinicalTrials.gov |
What this trial studies
This research compares two methods of monitoring chronic wounds: a smartphone app for remote wound monitoring and traditional in-person monitoring at a clinic. The study will enroll 120 patients with active diabetic foot ulcers and randomly assign them to either the remote monitoring group or the standard care group for 12 weeks. The goal is to assess the practicality and effectiveness of the app in managing wound care and to evaluate patient and provider satisfaction alongside wound healing outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an active diabetic foot ulcer who can use a smartphone for wound assessment.
Not a fit: Patients with wounds that cannot be adequately monitored with the app or those without access to a caregiver for assistance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more convenient and effective way for patients to manage diabetic foot ulcers, potentially improving healing rates.
How similar studies have performed: Other studies have shown promise in remote monitoring technologies for wound care, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Caitlin Hicks, MD — Johns Hopkins School of Medicine
- Study coordinator: Caitlin Hicks, MD
- Email: chicks11@jhmi.edu
- Phone: 410-955-5165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.