Actively Recruiting
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
Led by Johns Hopkins University · Updated on 2025-01-24
120
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research 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.
CONDITIONS
Official Title
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 6 18 years old
- Currently receiving treatment for a lower extremity wound related to diabetic foot ulcer
- Able and willing to use a smartphone to assess the wound for the study duration
- Proficient in English language
You will not qualify if you...
- Patients with fewer than 1 dressing change per week
- Patients with wound size too large to be covered with a single app scan (such as wounds wrapping around the entire leg)
- Patients with wounds in locations that are difficult to access who do not have a caregiver to assist with wound scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Caitlin Hicks, MD
CONTACT
S
Sherry Leung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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