Venous Insufficiency Clinical Trial
The purpose of this study is to prove the safety and efficacy of plasma as an add-on treatment in combination with conventional treatment in cases of chronical venous Ulcus cruris.
Ulcus cruris consists of pathologically changed tissue of the lower leg. Up to 80% are of
venous origin. Because of the high prevalence of up to 2% the treatment of Ulcus cruris is
of special economical importance. Depending on the size, depth and possible infections, the
conventional treatment of these wounds consists of an adequate compression, preparation of
the lesion, cover and of appropriate control of infections. All tasks are undertaken in
order to faciliate the healing of these chronic wounds.
Plasma consists of free ions or electrons and can be created by various techniques.
Commonly, it is use in the sterilization of medicinal equipment, the cauterization of tissue
and in the field of coagulation. Because of its bactericidal characteristics, the direct
interaction of plasma created by temperatures below 40°C on tissue is intensively studied.
Both in vitro and in vivo studies proved a significant reduction of bacterial contamination
in different test systems. As bacterial contamination might slow down wound healing, plasma
treatment might be a useful tool to complement conventional methods in the treatment of
chronical wounds.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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