# Enhanced ultrasound treatment of chronic wounds with monitoring of healing and quality of life outcomes

> **NIH NIH R01** · DREXEL UNIVERSITY · 2020 · $608,359

## Abstract

Project Summary / Abstract
 The two most common types of chronic wounds are venous ulcers (VUs) and diabetic ulcers (DUs). We
will conduct the first double-blind randomized controlled trial (RCT) to test the effect of low-frequency, low-
intensity (LFLI) ultrasound (US) on chronic wound healing and health related quality of life (HRQOL) with high
statistical confidence (α < 0.05, power > 0.90, n=60 VUs, n=60 DUs). Our approach combines this active
therapy with non-invasive diagnostic monitoring of wound hemodynamics throughout the treatment cycle, and
includes analysis of the impact of nutritional status and inflammation on wound closure. There are several
innovative aspects of this work. Specifically, (1) Our lightweight, battery-powered applicator is the first
potentially wearable ultrasound wound therapy device that is safe to apply for extended periods of time. (2)
The applicator actively promotes healing, which is fundamentally different from commercial ultrasonic systems
that remove necrotic tissue only. (3) Our approach will link LFLI US exposure to changes in wound
hemodynamics and HRQOL, which has the potential to enable personalized medicine. (4) Our analysis of
patient nutritional and systemic inflammatory status may enable further treatment customization by identifying
those patients most likely to benefit from LFLI US therapy. (5) Our approach incorporates both disease-specific
and generic measures of HRQOL, which is unique for a therapeutic ultrasound RCT.
 Our low-frequency, low-intensity (20 kHz, <100 mW/cm2 spatial peak-temporal peak), portable ultrasound
applicator is safe and clinically pragmatic wound treatment. The field
lightweight (<25g) and permits
parameters of our US device were previously optimized for venous ulcers, and our three recent pilot clinical
human studies (VUs: n=20, n=25; DUs: n=10) demonstrated that our treatment improved healing by 15% per
week compared to sham treatment. We therefore anticipate that our treatment will accelerate closure of
chronic wounds, and we hypothesize that (1) LFLI US will improve generic and disease-specific HRQOL
scores, (2) LFLI US will activate beneficial changes in the microvasculature of the wound and surrounding
tissue, and (3) individuals with poor nutrition and high levels of inflammation will have delayed wound healing.
 Our specific aims are to: (1) Assess the effect of LFLI US on VUs and DUs by measuring wound closure
as a primary endpoint and generic and disease-specific HRQOL as secondary endpoints. (2) Monitor the
effects of LFLI US on wound perfusion and oxygenation using non-invasive optical methods, and (3) Determine
the impact of nutritional status and inflammation on closure of DUs and VUs. Overall, this work will validate
LFLI US as a safe, portable, and cost-effective therapy for chronic wounds. This is important because new
therapies and improved clinical paradigms for wound management are urgently needed. Over the long-term,
our findings may enable the develo...

## Key facts

- **NIH application ID:** 9955381
- **Project number:** 5R01NR015995-05
- **Recipient organization:** DREXEL UNIVERSITY
- **Principal Investigator:** Peter A. Lewin
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $608,359
- **Award type:** 5
- **Project period:** 2016-09-27 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9955381

## Citation

> US National Institutes of Health, RePORTER application 9955381, Enhanced ultrasound treatment of chronic wounds with monitoring of healing and quality of life outcomes (5R01NR015995-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9955381. Licensed CC0.

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