Chronic leg ulcers that heal poorly can become infected, lead to limb amputation, and severely compromise quality of life. More than 80% of all chronic leg ulcers are venous leg ulcers1 (VLUs) caused by abnormal back flow in the veins of the lower leg. The increased pressure forces fluid to seep from the veins into the tissues of the leg, causing swelling, inflammation, and ultimately breakdown of the skin that creates a wound. Approximately 1% of adults are estimated to suffer from VLUs2 and experience reduced quality of life (QOL) due to lost productivity, significant morbidity, and high rates or recurrence. In the United States alone, the annual economic burden of VLUs is estimated to be up to $18 billion3. Timely intervention is critical to reducing these costs and improving patient outcomes. Guidelines for treating VLUs have been published, but stalled healing and high recidivism in VLUs show that standard care is often insufficient.
New technologies are bringing more effective treatment options for VLUs, says Dr. William Li, President and Medical Director of the Angiogenesis Foundation. One such technology uses low frequency ultrasound and is featured in a new clinical study published by Dr. Li and co-authors in Ostomy Wound Management. The study is titled “A Prospective, Randomized, Controlled Trial Comparing the Effect of Noncontact, Low-frequency Ultrasound to Standard Care in Healing Venous Leg Ulcers“. In this study, called IN BALANCE, the effect of non-contact low-frequency ultrasound (NLFU) (MIST Therapy) added to standard care for treating VLU was compared to standard care alone. The NFLU treatment system delivers low-frequency (40 kHz) ultrasound energy into and below the surface of the wound without direct contact with the patient. This stimulates angiogenesis, new blood vessel growth, in the wound and also has been shown in the laboratory to recruit the body’s stem cells to aid in healing.
The IN BALANCE study demonstrated that after 4 weeks of care, patients receiving standard care plus MIST Therapy saw a significantly greater percentage reduction in wound area than those who received standard care alone (62% reduction compared to 45% reduction, respectively). In addition, patients who received standard care plus MIST Therapy reported an 80% reduction in pain scores compared to a 20% reduction in those who received only standard care. Finally, during the 11-week follow-up period, a higher proportion of standard care plus MIST Therapy healed more ulcers completely compared to standard care alone. The study authors conclude that the benefits of MIST Therapy are tied to its ability to addresses defects at a microenvironment level.
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1. González‐Consuegra, Renata Virginia, and José Verdú. “Quality of life in people with venous leg ulcers: an integrative review.” Journal of advanced nursing 67.5 (2011): 926-944.
2. Abbade, Luciana P. Fernandes, and Sidnei Lastória. “Venous ulcer: epidemiology, physiopathology, diagnosis and treatment.” International journal of dermatology 44.6 (2005): 449-456.
3. Gibbons, G. W., et al. “A Prospective, Randomized, Controlled Trial Comparing the Effects of Noncontact, Low-frequency Ultrasound to Standard Care in Healing Venous Leg Ulcers.” Ostomy/wound management 61.1 (2015): 16-29.