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

This study has been completed.
Sponsor:
Collaborators:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Information provided by:
Cinogy GmbH
ClinicalTrials.gov Identifier:
NCT01415622
First received: August 11, 2011
Last updated: November 16, 2012
Last verified: August 2011
  Purpose

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.


Condition Intervention
Venous Insufficiency
Device: PlasmaDerm
Procedure: standard care of Ulcera crurum

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

Further study details as provided by Cinogy GmbH:

Primary Outcome Measures:
  • number of SAEs [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • inflammation of the Ulcus crurus [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • size of the Ulcus crurus [ Time Frame: once a week ] [ Designated as safety issue: No ]
  • pain assessment between treatments [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • pain assessment during treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • patient satisfaction (patient-benefit-index) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • overall assessment of the treatment from patient's view [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • overall assessment of the treatment from investigator's view [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • relapse rate 4 weeks after end of treatment [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PlasmaDerm
Treatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care.
Device: PlasmaDerm
plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.
standard care
standard care of Ulcera crurum
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.

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415622

Locations
Germany
Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital
Göttingen, Germany
Sponsors and Collaborators
Cinogy GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
Investigators
Principal Investigator: Steffen Emmert, Prof. Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Dirk Wandke, Cinogy GmbH
ClinicalTrials.gov Identifier: NCT01415622     History of Changes
Other Study ID Numbers: 20101028
Study First Received: August 11, 2011
Last Updated: November 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cinogy GmbH:
plasma therapy
ulcus cruris

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014