MedDataX Logo

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

NCT ID: NCT01415622

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Insufficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

plasma therapy ulcus cruris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PlasmaDerm

Treatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care.

Group Type EXPERIMENTAL

PlasmaDerm

Intervention Type DEVICE

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

Group Type OTHER

standard care of Ulcera crurum

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PlasmaDerm

plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role collaborator

University Medical Center Goettingen

OTHER

Sponsor Role collaborator

Cinogy GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cinogy GmbH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steffen Emmert, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Göttingen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.

Reference Type DERIVED
PMID: 24666170 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.cinogy.de/

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20101028

Identifier Type: -

Identifier Source: org_study_id