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

Primary Purpose

Venous Insufficiency

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

PlasmaDerm

standard care of Ulcera crurum

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring plasma therapy, ulcus cruris

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PlasmaDerm

standard care

Arm Description

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

standard care of Ulcera crurum

Outcomes

Primary Outcome Measures

number of SAEs

Secondary Outcome Measures

inflammation of the Ulcus crurus

size of the Ulcus crurus

pain assessment between treatments

pain assessment during treatment

patient satisfaction (patient-benefit-index)

overall assessment of the treatment from patient's view

overall assessment of the treatment from investigator's view

relapse rate 4 weeks after end of treatment

Full Information

NCT ID

NCT01415622

First Posted

August 11, 2011

Last Updated

November 16, 2012

Sponsor

Cinogy GmbH

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01415622

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cinogy GmbH

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Insufficiency

Keywords

plasma therapy, ulcus cruris

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PlasmaDerm

Arm Type

Experimental

Arm Description

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

Arm Title

standard care

Arm Type

Other

Arm Description

standard care of Ulcera crurum

Intervention Type

Device

Intervention Name(s)

PlasmaDerm

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

standard care of Ulcera crurum

Intervention Description

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.

Primary Outcome Measure Information:

Title

number of SAEs

Time Frame

2 months

Secondary Outcome Measure Information:

Title

inflammation of the Ulcus crurus

Time Frame

2 months

Title

size of the Ulcus crurus

Time Frame

once a week

Title

pain assessment between treatments

Time Frame

2 months

Title

pain assessment during treatment

Time Frame

2 months

Title

patient satisfaction (patient-benefit-index)

Time Frame

2 months

Title

overall assessment of the treatment from patient's view

Time Frame

2 months

Title

overall assessment of the treatment from investigator's view

Time Frame

2 months

Title

relapse rate 4 weeks after end of treatment

Time Frame

after 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steffen Emmert, Prof.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Göttingen

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24666170

Citation

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.

Results Reference

derived

Links:

URL

http://www.cinogy.de/

Description

Related Info

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

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