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

November 16, 2012 updated by: Cinogy GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany
        • Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of SAEs
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
inflammation of the Ulcus crurus
Time Frame: 2 months
2 months
size of the Ulcus crurus
Time Frame: once a week
once a week
pain assessment between treatments
Time Frame: 2 months
2 months
pain assessment during treatment
Time Frame: 2 months
2 months
patient satisfaction (patient-benefit-index)
Time Frame: 2 months
2 months
overall assessment of the treatment from patient's view
Time Frame: 2 months
2 months
overall assessment of the treatment from investigator's view
Time Frame: 2 months
2 months
relapse rate 4 weeks after end of treatment
Time Frame: after 4 weeks
after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cinogy GmbH

Collaborators

University Medical Center Goettingen
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Investigators

  • Principal Investigator: Steffen Emmert, Prof., Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 16, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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