NCT01415622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 19, 2012

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 11, 2011

Last Update Submit

November 16, 2012

Conditions

Venous Insufficiency

Keywords

plasma therapyulcus cruris

Outcome Measures

Primary Outcomes (1)

  • number of SAEs

    2 months

Secondary Outcomes (8)

  • inflammation of the Ulcus crurus

    2 months

  • size of the Ulcus crurus

    once a week

  • pain assessment between treatments

    2 months

  • pain assessment during treatment

    2 months

  • patient satisfaction (patient-benefit-index)

    2 months

  • +3 more secondary outcomes

Study Arms (2)

PlasmaDerm

EXPERIMENTAL

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

Device: PlasmaDerm

standard care

OTHER

standard care of Ulcera crurum

Procedure: standard care of Ulcera crurum

Interventions

PlasmaDermDEVICE

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

PlasmaDerm
standard care of Ulcera crurumPROCEDURE

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.

standard care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Göttingen, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24666170DERIVED

Related Links

MeSH Terms

Conditions

Venous InsufficiencyFoot Ulcer

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Study Officials

  • Steffen Emmert, Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

November 19, 2012

Record last verified: 2011-08

Locations

DE(1)