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

Venous Insufficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415622
• Other study ID #: 20101028
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: November 16, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2011
• Source: Cinogy GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• PlasmaDerm
plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.

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.

Locations

Country	Name	City	State
Germany	Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital	Göttingen

Sponsors (3)

Lead Sponsor	Collaborator
Cinogy GmbH	Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH, University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of SAEs		2 months	Yes
Secondary	inflammation of the Ulcus crurus		2 months	Yes
Secondary	size of the Ulcus crurus		once a week	No
Secondary	pain assessment between treatments		2 months	No
Secondary	pain assessment during treatment		2 months	No
Secondary	patient satisfaction (patient-benefit-index)		2 months	No
Secondary	overall assessment of the treatment from patient's view		2 months	No
Secondary	overall assessment of the treatment from investigator's view		2 months	No
Secondary	relapse rate 4 weeks after end of treatment		after 4 weeks	No

External Links

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