Venous InsufficiencyNCT01415622
Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
A study testing PlasmaDerm in people with Venous Insufficiency, run by Cinogy GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- PlasmaDerm
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. of Dermatology, Venerology and Allergology, Göttingen University Hospital
Göttingen
About this study
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.
Read the 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.
- Conditions
- Venous Insufficiency
- Being tested
- PlasmaDerm, standard care of Ulcera crurum
- Keywords
- plasma therapy, ulcus cruris
- Medical subject headings
- Venous Insufficiency, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaDermDevice
plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.
standard care of Ulcera crurumProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PlasmaDerm | Experimental | Treatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care. Receives: Device: PlasmaDerm |
| standard care | Other | standard care of Ulcera crurum Receives: Procedure: standard care of Ulcera crurum |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of SAEs
Measured: 2 months
Secondary outcomes (8)
inflammation of the Ulcus crurus
Measured: 2 months
size of the Ulcus crurus
Measured: once a week
pain assessment between treatments
Measured: 2 months
pain assessment during treatment
Measured: 2 months
patient satisfaction (patient-benefit-index)
Measured: 2 months
overall assessment of the treatment from patient's view
Measured: 2 months
overall assessment of the treatment from investigator's view
Measured: 2 months
relapse rate 4 weeks after end of treatment
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinogy GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH, University Medical Center Goettingen
- Investigators
- Steffen Emmert, Prof., Principal investigator, Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415622
- Sponsor's protocol ID
- 20101028
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2011
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24666170
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Efficacy, and Safety of Venous Ulcer Treatment Using a Hand Plasma Generator (PlasmaDerm) Chronisch venöser Ulzerationen (PlasmaDerm)
- ClinicalTrials.gov ID
- NCT01415622
- Acronym / sponsor ID
- 20101028
- Conditions
- Venous Insufficiency
- Keywords
- plasma therapy, ulcus cruris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cinogy GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH, University Medical Center Goettingen
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlasmaDerm | Experimental | Device: PlasmaDermTreatment of small to medium-sized Ulcera crurum with the PlasmaDerm VU-2010 device in addition to standard care. |
| standard care | Other | Procedure: standard care of Ulcera crurumstandard care of Ulcera crurum |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmaDermplasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care. | Device | PlasmaDerm |
| standard care of Ulcera crurumstandard 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. | Procedure or surgery | standard care |
Primary outcome
number of SAEs
Time frame: 2 months
8 secondary outcomes
inflammation of the Ulcus crurus
Time frame: 2 months
size of the Ulcus crurus
Time frame: once a week
pain assessment between treatments
Time frame: 2 months
pain assessment during treatment
Time frame: 2 months
patient satisfaction (patient-benefit-index)
Time frame: 2 months
overall assessment of the treatment from patient's view
Time frame: 2 months
overall assessment of the treatment from investigator's view
Time frame: 2 months
relapse rate 4 weeks after end of treatment
Time frame: after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- Derived from this study: PubMed 24666170Brehmer 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Emmert, Prof. principal investigator
Dept. of Dermatology, Venerology and Allergology, Göttingen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlasmaDerm in people with Venous Insufficiency, run by Cinogy GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of SAEs (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.