AI-Powered Remote Monitoring for Lower Extremity Wound Management: A Randomized Controlled Trial Protocol.
Y H Andrew Wu, Alana C Keegan, Midori P Starks White...
https://pubmed.ncbi.nlm.nih.gov/40857414Actively Recruiting
Led by Johns Hopkins University · Updated on 2025-01-24
120
Participants Needed
1
Research Sites
168 weeks
Total Duration
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
Researchers are evaluating two different wound monitoring methods for patients with active diabetic foot ulcers: remote monitoring using a smartphone app versus traditional in-person monitoring at a clinic. This pilot study is a non-blinded randomized controlled feasibility trial involving 120 patients receiving care at a multidisciplinary diabetic foot clinic in Baltimore, Maryland. The aim is to assess whether the smartphone app can offer a practical, patient-centered solution for regular wound assessment and management compared to standard care, while also measuring patient and provider satisfaction and wound healing outcomes. Participants will be randomly assigned to either use the Healthy.io mobile app for remote wound monitoring or continue with standard in-person wound care for 12 weeks. The app captures wound measurements and tissue analysis in real time, allowing patients to perform self-scans of their wounds which are automatically sent to medical professionals for review. This remote monitoring system enables timely clinical interventions if the wound shows signs of stagnation or worsening. Throughout the 12-week study, researchers will track the proportion of participants who successfully complete weekly wound scans. Participants will need to use the smartphone app regularly or attend clinic visits depending on their group. The study involves ongoing clinical oversight, wound assessments, and comparisons of healing progress. The goal is to determine the feasibility and effectiveness of the remote monitoring program in managing diabetic foot ulcers.
CONDITIONS
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
C
Caitlin Hicks, MD
S
Sherry Leung
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Y H Andrew Wu, Alana C Keegan, Midori P Starks White...
https://pubmed.ncbi.nlm.nih.gov/40857414