Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
|ClinicalTrials.gov Identifier: NCT01415622|
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : November 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency||Device: PlasmaDerm Procedure: standard care of Ulcera crurum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Treatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care.
plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.
standard care of Ulcera crurum
Procedure: standard care of Ulcera crurum
standard care of Ulcera crurum: Mepithel gaze for non-exsudative wounds, Mepilex for exsudative wounds, followed by surgical hose treatment. Additionally, a standardized compression therapy with Ulcer X is applied.
- number of SAEs [ Time Frame: 2 months ]
- inflammation of the Ulcus crurus [ Time Frame: 2 months ]
- size of the Ulcus crurus [ Time Frame: once a week ]
- pain assessment between treatments [ Time Frame: 2 months ]
- pain assessment during treatment [ Time Frame: 2 months ]
- patient satisfaction (patient-benefit-index) [ Time Frame: 2 months ]
- overall assessment of the treatment from patient's view [ Time Frame: 2 months ]
- overall assessment of the treatment from investigator's view [ Time Frame: 2 months ]
- relapse rate 4 weeks after end of treatment [ Time Frame: after 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415622
|Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital|
|Principal Investigator:||Steffen Emmert, Prof.||Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital|