Clinical trial NCT01415622: Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: plasma therapy
ulcus cruris
Lead sponsor: Cinogy GmbH
Sponsor class: INDUSTRY
Collaborators: name: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
name: University Medical Center Goettingen
First posted: 2011-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: number of SAEs
timeFrame: 2 months
Secondary outcomes:
measure: inflammation of the Ulcus crurus
timeFrame: 2 months
measure: size of the Ulcus crurus
timeFrame: once a week
measure: pain assessment between treatments
timeFrame: 2 months
measure: pain assessment during treatment
timeFrame: 2 months
measure: patient satisfaction (patient-benefit-index)
timeFrame: 2 months
measure: overall assessment of the treatment from patient's view
timeFrame: 2 months
measure: overall assessment of the treatment from investigator's view
timeFrame: 2 months
measure: relapse rate 4 weeks after end of treatment
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital
Study officials:
affiliation: Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital
name: Steffen Emmert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.