# Reducing time to heal chronic leg wounds through monitoring, engagement and intelligent intervention via WoundAlert system

> **NIH NIH R43** · SURAMEDICAL, LLC · 2021 · $299,977

## Abstract

Project Summary/ Abstract
Significance: There is a clear unmet need to reduce the treatment time and cost of the more than 3 million
patients with chronic leg wounds draining 3% of annual healthcare expenditure in the US alone. Standard care
is to manage wound moisture through dressing changes, swelling through multilayer compression wraps for
venous wounds and offloading via removable cast walker for diabetic wounds, and to prescribe daily
ambulation and elevation on the part of both types of patient. Wound dressings are changed once or twice a
week based on guesswork by specialists at a wound care center or in the home by a visiting nurse for the 3-6
months (or longer) that is required to heal. While standard care has been demonstrated to effectively heal
chronic leg wounds, unfortunately in more than 50% of visits, wound dressings are changed too early or too
late, leading to lost healing days. Compression wraps lose therapeutic pressure or removable cast walkers are
not worn and patients often fail to ambulate more than 10 minutes per day or to elevate their wounded leg
while sedentary leading to further delays in healing. Innovation: SuraMedical’s proposed Phase I research
seeks to demonstrate the clinical efficacy of our innovative prototype WoundAlert treatment monitoring system
in reducing the time to heal chronic leg wounds. WoundAlert enables real-time monitoring and optimization of
critical standard care treatment parameters such as dressing moisture and wrap pressure as well as patient
engagement and compliance through ambulation and leg elevation tracking. This is accomplished via a
wireless wearable sensor tag paired to a mobile app for patient data and engagement and overseen by a
clinician cloud dashboard interface. Preliminary Data: Research to date has involved development of
prototype hardware and software, lab and human subject performance testing, as well as exploring the
commercial opportunity with potential partners and investors. Study of the prototype system with healthy
volunteers has led to system improvements to be undertaken in Aim 1 of the proposed work in preparation for
clinical study in Aim 2. Specific Aims: Development of a minimum viable clinical prototype is the goal of
Aim 1 based on preliminary data and testing. Milestones are a clinical prototype system with 6-month battery
life and manufacturable design with <$20 cost at >10k quantity, validated by focus group testing with 10 wound
care providers. Aim 2 focuses on demonstrating WoundAlert system clinical efficacy in increasing the
rate of healing in venous leg wounds through a clinical study with real time monitoring of a 15 patient
intervention arm compared to a 15 patient control arm. The metric for success will be a statistically significant
(p<0.05) increase of greater than 10% in wound healing rate. Follow up work in Phase II will close the loop on
improvements illuminated by the proposed Phase I work and lead to definitive efficacy studies, FDA
submis...

## Key facts

- **NIH application ID:** 10325512
- **Project number:** 1R43AG074834-01
- **Recipient organization:** SURAMEDICAL, LLC
- **Principal Investigator:** Jonathan M Engel
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $299,977
- **Award type:** 1
- **Project period:** 2021-09-05 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325512

## Citation

> US National Institutes of Health, RePORTER application 10325512, Reducing time to heal chronic leg wounds through monitoring, engagement and intelligent intervention via WoundAlert system (1R43AG074834-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10325512. Licensed CC0.

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