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Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (BF09-PH-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318785
Recruitment Status : Unknown
Verified September 2011 by University Medicine Greifswald.
Recruitment status was:  Recruiting
First Posted : March 18, 2011
Last Update Posted : September 7, 2011
Sponsor:
Collaborators:
KABEG Management
Nij Smellinghe Hosptial
Universitaire Ziekenhuizen Leuven
Information provided by:
University Medicine Greifswald

Brief Summary:

Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase

  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.

Condition or disease Intervention/treatment Phase
Lymphedema Other: Compression Armsleeves Phase 2

Detailed Description:
  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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
Study Start Date : September 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Active Comparator: Compression ArmsleevesType A
Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
Other: 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 Names:
  • Bauerfeind SoraLife
  • Jobst Elvarex

Active Comparator: Compression Armsleeves Type B
Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387
Other: 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 Names:
  • Bauerfeind SoraLife
  • Jobst Elvarex




Primary Outcome Measures :
  1. change of volume (arm and hand together) [ Time Frame: 6 weaks per patient ]

    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.



Secondary Outcome Measures :
  1. Clinical judgement of skin status [ Time Frame: 6 weaks per patient ]
    clinical judgement of skin status with photo documentation, clinical finding (as palpation,check on fibrosclerosis, skin clour, skin surface, edema, tenderness, tissue consistency...), check of skin contamination

  2. Wearing comfort and handling features of armsleeves [ Time Frame: 6 weeks per patient ]

    For both types of products questionaires are prepared to find out how patients are feeling with their armsleeves.It is asked for problems during donning procedure as well as during wearing period. This will be done in the beginning after 1 week and after 2 weeks for both types.

    At the end the study nurses are asked to their impression regarding patients acceptance of the armsleeves.

    Method: VAS score




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318785


Contacts
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Contact: Michael Jünger, Prof. Dr. +493834-866770 juenger@uni-greifswald.de
Contact: Claudia Eggert, Study Nurse +493834-866770 claudia.eggert@uni-greifswald.de

Locations
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Austria
Landeskrankenhaus Wolfsberg Recruiting
Wolfsberg, Kärnten, Austria, 9400
Contact: Walter Döller, MD       sekretariatlymph@lkh-wo.at   
Principal Investigator: Walter Döller, MD         
Belgium
Universitaire Ziekenhuizen Recruiting
Leuven, Belgium, 3000
Contact: Maria Flour, MD       maria.flour@uz.kuleuven.ac.be   
Principal Investigator: Maria Flour, MD         
Germany
Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße Recruiting
Greifswald, Mecklenburg Vorpommern, Germany, 17475
Contact: Michael Jünger, Prof. Dr.    +493834-866770    juenger@uni-greifswald.de   
Contact: Claudia Eggert, Study Nurse    +493834-866770    claudia.eggert@uni-greifswald.de   
Netherlands
Nij Smellinghe Hosptial Recruiting
Drachten, Netherlands, 9202
Contact: Robert Damstra, MD       r.damstra@nijsmellinghe.nl   
Principal Investigator: Robert Damstra, MD         
Sponsors and Collaborators
University Medicine Greifswald
KABEG Management
Nij Smellinghe Hosptial
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Michael Jünger, Prof. Dr. Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Additional Information:
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Responsible Party: Prof. Dr. med. Michael Jünger, Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
ClinicalTrials.gov Identifier: NCT01318785    
Other Study ID Numbers: Multicentrestudy "BF09-PH-01"
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011
Keywords provided by University Medicine Greifswald:
secondary arm-lymphedema
breast cancer related arm-lymphedema
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases