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

Cinogy

Status

Completed

Conditions

Venous Insufficiency

Treatments

Device: PlasmaDerm

Procedure: standard care of Ulcera crurum

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01415622

20101028

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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