Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
NCT ID: NCT01318785
Last Updated: 2011-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2011-09-30
2011-11-30
Brief Summary
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1. thesis:
\- all types should be equal regarding volume reduction
2. thesis: armsleeves manufactured with microfibre yarn are expected to be
* better in wearing comfort and
* better in handling features.
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Detailed Description
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* measuring of arm volume by "inverse water-volumetry" (see later)
* measuring of circumference cD
* measuring of circumference cG
* photodocumentation in 2 positions(during each round)
2. thesis
* questionaire for patients
* in the beginning
* after 1 week
* after 2 weeks (at the end of a wearing period)
* questionaire for study nurse (at the end of a wearing period)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Compression ArmsleevesType A
Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
Compression Armsleeves
Type: Compression Class II (according to RAL)
The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient.
Compression Armsleeves Type B
Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387
Compression Armsleeves
Type: Compression Class II (according to RAL)
The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient.
Interventions
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Compression Armsleeves
Type: Compression Class II (according to RAL)
The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* willingness to wear compression arm-sleeves for at least 12 hours per day
* maintenance phase, where no significant further reduction of arm-volume can be achieved
* lymphedema in stadium 1 or 2
* age: at least 18 years
* signed consent form by the patient
* sufficient knowledge in national language
Exclusion Criteria
* immobilized patient
* acute deep vein thrombosis in arm
* directly after arm-vein-thrombosis
* acute arm erysipelas
* malignant edema
* existent lipedema
* arterial occlusion
* distinctive neuropathy in upper limbs
* neurinoma in upper limbs
* chronic pain after plastic surgery in upper limbs, shoulder or breast
* change in drug treatment, that can influence edema situation during the study
* pregnant women
* breast giving mothers
* not signed consent form
* participation in a second clinical trial
18 Years
FEMALE
No
Sponsors
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KABEG Management
OTHER
Nij Smellinghe Hosptial
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
University Medicine Greifswald
OTHER
Responsible Party
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Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Principal Investigators
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Michael Jünger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Locations
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Landeskrankenhaus Wolfsberg
Wolfsberg, Carinthia, Austria
Universitaire Ziekenhuizen
Leuven, , Belgium
Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
Greifswald, Mecklenburg-Vorpommern, Germany
Nij Smellinghe Hosptial
Drachten, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Related Links
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link to Greifswald dermatology
Other Identifiers
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Multicentrestudy "BF09-PH-01"
Identifier Type: -
Identifier Source: org_study_id
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