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

NCT01415622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-11-19

No results posted yet for this study

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.

Conditions

  • Venous Insufficiency

Interventions

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.

Sponsors & Collaborators

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    collaborator OTHER

  • University Medical Center Goettingen

    collaborator OTHER

  • Cinogy GmbH

    lead INDUSTRY

Principal Investigators

  • Steffen Emmert, Prof. · Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415622 on ClinicalTrials.gov