Status:
COMPLETED
Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
Lead Sponsor:
Cinogy GmbH
Collaborating Sponsors:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Conditions:
Venous Insufficiency
Eligibility:
All Genders
50+ years
Phase:
NA
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 economic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01415622
Start Date
April 1 2011
End Date
August 1 2012
Last Update
November 19 2012
Active Locations (1)
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1
Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital
Göttingen, Germany