Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: PlasmaDerm
* Procedure: standard care of Ulcera crurum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persons of both gender aged 50 and older; females must be in menopause for at least one year at least one chronical venous ulcerisation at one or both legs with the following characteristics: size between 5 cm² and 30 cm²; duration 12 weeks to 10 years; located between knee and ankle; dermis and subkutis being involved, without damage of muscles, bones or tendon vital wound ground with granulation tissue proof of ulcerisation caused by venous malformation by duplex sonography, the tibiobrachiale index being between 0.8 and 1.3 no active wound treatment one week before study treatment starts Exclusion Criteria: females not being in menopause non-venous cause for ulzerisation lymphatic oedema, wound infection, necrotic tissue, venous fistula, bradytrophe wound ground clinical treatment of the venes during the last three months background therapy with systemic corticosteroides above Cushing-level (7.5 mg Prednisolonequivalent) previous radiation treatment of the ulzerisation area patients with defibrillator, after organ transplantation, cardiac insufficiency, known connective tissue disease, malnutrition (Albumin i.S. < 2.5 g/dl), Diabetes mellitus (HbA1c > 8%), active maligne disease, severe rheumatoide arthritis, hemodialysis, active sickle cell anemia known alcohol or drug abuse patients currently participating or having participated during the last 4 weeks in another clinical trial patients being unable to understand the intention of the clinical trial patients being not compliant or not being independant from the sponsor or investigator missing approval to collect and process pseudomized data hospitalization in a mental institution due to § 20 MPG

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlasmaDerm<br>Treatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care. | Device: PlasmaDerm<br>* plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.<br>|
| Other: standard care<br>standard care of Ulcera crurum | Procedure: standard care of Ulcera crurum<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of SAEs |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation of the Ulcus crurus |  | 2 months | 
| size of the Ulcus crurus |  | once a week | 
| pain assessment between treatments |  | 2 months | 
| pain assessment during treatment |  | 2 months | 
| patient satisfaction (patient-benefit-index) |  | 2 months | 
| overall assessment of the treatment from patient's view |  | 2 months | 
| overall assessment of the treatment from investigator's view |  | 2 months | 
| relapse rate 4 weeks after end of treatment |  | after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma therapy, ulcus cruris