AI-Powered Remote Monitoring for Lower Extremity Wound Management: A Randomized Controlled Trial Protocol

Lower extremity wounds associated with diabetes are a serious global health issue, with diabetic foot ulcers affecting 12% to 25% of adults with diabetes and accounting for 80-90% of all lower extremity amputations in the United States. Comprehensive in-person care for lower extremity wounds is important but can be burdensome for patients and costly for healthcare systems. A cost-effective telehealth model using a smartphone-integrated digital application that remotely analyzes wound status with machine-learning algorithms in real-time could make lower extremity wounds care more accessible to patients. This trial aims to determine if an artificial intelligence (AI)-powered digital remote monitoring is a feasible, patient-centered solution for remote wound monitoring and management compared to standard in-person visits.

We will conduct a non-blinded randomized control trial of 120 patients with active lower extremity wounds treated in the Johns Hopkins Hospital Multidisciplinary Diabetic Foot and Wound Clinic in Baltimore, Maryland (ClinicalTrials.gov: NCT05579743). Participants will be randomly assigned 1:1 to receive wound care monitoring using AI-powered remote wound monitoring technology (Healthy.io Ltd.) or standard in-person monitoring for 12 weeks. The primary aim is to establish the feasibility of a novel remote patient-centered monitoring program for the surveillance and monitoring of lower extremity wounds. Secondary aims include evaluating patient and provider satisfaction with remote wound monitoring technology compared to standard in-person monitoring; and generating pilot data on wound healing time and major amputation rates in patients who are monitored remotely compared to patients treated with standard of care.

This trial will determine whether AI-powered remote digital monitoring is feasible and acceptable as an alternative to standard in-person monitoring for the monitoring and management of patients with active lower extremity wounds.