Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
18 Years
N/A
Female
Lymphedema
Trial Information
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
1. thesis:
- 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)
Inclusion Criteria:
- women with a secondary arm-lymphedema for at least 3 months
- 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:
- edema not completely reduced to "maintenance phase"
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
change of volume (arm and hand together)
Outcome Description:
During a 2-weeks-phase the volume of patients arm and hand together is measured once a week, e.g. 3 times (beginning, after 1 week, at the end). This is done with armsleeves of the first type. After one week of sedation the test will be repeated with the second product. Randomization is given by chance, that during first phase product of type A or type B can be applied. During second phase then vice versa. The measurements were performed by an "inverse water plethysmography device" (later: inverse watervolumetry) desinged by R. Damstra.
Outcome Time Frame:
6 weaks per patient
Safety Issue:
No
Principal Investigator
Michael Jünger, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Multicentrestudy "BF09-PH-01"
NCT ID:
NCT01318785
Start Date:
September 2011
Completion Date:
November 2011
Related Keywords:
- Lymphedema
- secondary arm-lymphedema
- breast cancer related arm-lymphedema
- Lymphedema
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