Theragnostic Acousto-Optic Chronic Wound Management Device
(P. Lewin, and M. Weingarten)
Abstract: Drexel researchers have developed a light-weight, wearable low-power, low-frequency ultrasound applicator that can be used for the treatment of chronic wounds. This device has been tested in a limited clinical study, in which chronic venous ulcer wounds were treated at Dr. Weingarten’s Wound Management Center, Drexel College of Medicine.
The treatment of chronic wounds, including diabetic, venous, and decubitus ulcers has an annual cost of over $25 billion on the American health system, of which venous leg ulcers (initially targeted here) contributed nearly $1 billion dollars.
Two small clinical pilot studies have been conducted to determine the effectiveness of low frequency, low-intensity ultrasound on the treatment of venous ulcers. The first pilot study (n=20) focused on finding the optimal treatment parameters. Patients were randomly assigned to one of three treatment groups: 15 minutes at 20 kHz, 45 minutes at 20 kHz, and 15 minutes at 100 kHz, as well as a control (untreated) group. The ultrasound treatment was applied once a week for four weeks. At the end of the four week period there were healed and non-healed wounds in each group except that in the 15 min/20 kHz group all 5 patients’ wounds have healed. The second pilot study (n=19) focused on the 20 kHz for 15 minute treatment which performed best in the first pilot study. Patients were assigned to either treatment or the control group and were treated over 12 visits (typically weekly). The treated group had an average reduction in wound size of 8.2%/week whereas the untreated group had an increase in wound size of over 7%/week (p<0.05). Optical measurements of blood flow as well as in-vitro work have supported the wound size findings as well.
The success of this pilot study was featured on the National Institute of Health Press Release Website.
The clinical study was published in the Journal of Acoustical Society of America
This technology is protected by a pending U.S. Patent Application.