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

> **NIH NIH R03** · JOHNS HOPKINS UNIVERSITY · 2022 · $94,500

## Abstract

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.

## Key facts

- **NIH application ID:** 10509442
- **Project number:** 1R03DK133557-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Caitlin Whitney Hicks
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $94,500
- **Award type:** 1
- **Project period:** 2022-09-10 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10509442

## Citation

> US National Institutes of Health, RePORTER application 10509442, Feasibility and effectiveness of a pilot remote monitoring program for the treatment of diabetic foot ulcers (1R03DK133557-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10509442. Licensed CC0.

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