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

Not Applicable

Completed

• Conditions: Venous Insufficiency

• Registration Number: NCT01415622
• Lead Sponsor: Cinogy GmbH

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.

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of SAEs	2 months

Secondary Outcome Measures

Name	Time	Method
overall assessment of the treatment from patient's view	2 months
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 investigator's view	2 months
relapse rate 4 weeks after end of treatment	after 4 weeks

Trial Locations

Locations (1)

Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital; 🇩🇪 Göttingen, Germany