Feasibility and effectiveness of a pilot remote monitoring program for the treatment of diabetic foot ulcers

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PROJECT SUMMARY/ABSTRACT Caitlin W. Hicks MD, MS is an Associate Professor of Surgery in the Department of Surgery at Johns Hopkins University School of Medicine. She currently holds a K23 Mentored Career Development Award from the NIDDK focused on the risk factors, outcomes, and proteomics of diabetic peripheral neuropathy. She seeks an R03 award to expand her research focus to a clinical trial that will inform her research and clinical management of adults with diabetes and lower extremity complications. Dr. Hicks’ research proposal details a pilot randomized controlled feasibility trial of a novel remote wound monitoring program for the treatment of diabetic foot ulcers (DFUs). The specific aims of the research agenda are to 1) Establish the feasibility of a novel remote patient-centered monitoring program for the surveillance and monitoring of DFUs; 2) Assess patient and provider satisfaction with remote DFU monitoring technology compared to standard in-person monitoring; and 3) Generate pilot data on wound healing time and major amputation risk in patients with DFU who are monitored remotely compared to DFU patients treated with standard of care. One-hundred and twenty 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. Patients enrolled in the remote wound monitoring technology arm will upload weekly wound photos using a smartphone application to a dedicated portal where the care team can monitor the wound progression over time, and attend scheduled in-person follow-up at enrollment, week 4, week 8, and week 12. 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 an in- person wound assessment. Outcomes will include technology feasibility (defined as the number of participants who successfully complete at least one remote wound scan per week); patient engagement and app usability, patient satisfaction, and provider satisfaction (based discrete and open-ended survey questions at study completion); and wound size reduction at 12 weeks (%), wound healing time (days), and major amputation. This study will provide actionable data about the feasibility of using remote DFU monitoring technology in disadvantaged patients, possibly improving patient satisfaction and wound healing outcomes compared to standard in-person monitoring. The results will provide preliminary data to support a R01 grant submission that will rigorously evaluate this technology in the setting of a large randomized clinical trial. By providing pilot and feasibility data to help support a subsequent R01, this R03 proposal will enhance the capability of Dr. Hicks to transition to an independent investigator.