Leg Ulcers Venous Clinical Trial
Official title:
Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation
The demographic shift and the increasing prevalence of chronic wounds represent major
challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial
ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress.
Patients suffer from pain and immobility, which dramatically reduces their quality of life.
Complications such as infections or tissue necrosis can lead to a bad outcome and amputation
of extremities.
The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines
the technologies of pulse modulated magnetic fields and light emission locally applied to the
wound area. The investigational medical device represents a promising combinational
therapeutic approach to synergistically increase the tissues regenerative potential. By
stimulating electrophysiological processes at the site of injury, the cells regain its
capacity to efficiently regenerate the injured or diseased tissue. It is expected that the
patient benefits from a faster healing process, reduced inflammation as well as an improved
overall treatment outcome.
n/a
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