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20 Khz, Ultrasound Assisted Treatment of Chronic Wounds With Concurrent Optic Monitoring: A Human Study
Abstract   Peer reviewed

20 Khz, Ultrasound Assisted Treatment of Chronic Wounds With Concurrent Optic Monitoring: A Human Study

Peter A. Lewin, Christopher Bawiec, Youhan Sunny, Michael Weingarten, Joshua Samuels, Leonid Zubkov, David Margolis and Michael Neidrauer
Ultrasound in medicine & biology, v 41(4), pp S65-S66
Apr 2015
DOI: https://doi.org/10.1016/j.ultrasmedbio.2014.12.278

Abstract

Objectives : The objective of this work was to verify that low energy, tens of kHz frequency ultrasound was clinically viable in promoting chronic venous ulcer (VLU) wounds healing with concurrent optic monitoring of the healing process. Over 500,000 patients are treated for venous ulcers annually and constitute approximately 1% of total health care costs in the western world. The direct wound care costs associated with venous ulcers exceeds $2,400 per month, before factoring in indirect costs due to pain and limited productivity. Hence, even modest (25%) shortening of the time needed for healing would allow substantial cost savings. Methods : Patients (n=16) with venous ulcers that have been documented for a minimum of 8 weeks were enrolled from the Drexel Wound Healing Center according to the protocol approved by the University IRB, and randomly assigned into treatment or control groups. Patients were treated weekly (15 minutes) for a maximum of 12 visits or until wound closure using a novel, fully wearable, tether-free, ultrasound applicator operating at 20 kHz and generating pressure amplitudes close to 55 kPa (about 100 mW/cm2, ISPTP). The treatments were given in addition to standard of care compression therapy as ordered by the physician. Concurrently with ultrasound treatment, non-invasive optical diffuse spectroscopy was successfully used to monitor the ulcers’ healing status by measuring tissue oxygenation and blood flow in the capillary network. Results : Of the patients attending at least 3 sessions (n=16), the ultrasound treated group had statistically improved (p<0.04) rate of wound size change (reduction of 8.2%/wk) compared to the rate of wound size change for the control group (increase of 7.5%/wk on average). The optical system provided an early prognosis tool for the monitoring of healing outcomes, potentially enabling an agile intervention and customization of wound management. Conclusions : This study supports the notion that active low frequency ultrasound treatment of chronic venous ulcers combined with the current standard of care promotes the healing process and can potentially be performed at the patient’s home, away from the clinical setting.

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