Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

Overview

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.

Full Title of Study: “Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2011

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)

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Compression ArmsleevesType A
    • Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
  • Active Comparator: Compression Armsleeves Type B
    • Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medicine Greifswald
  • Collaborator
    • KABEG Management
  • Provider of Information About this Clinical Study
    • Prof. Dr. med. Michael Jünger, Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
  • Overall Official(s)
    • Michael Jünger, Prof. Dr., Principal Investigator, Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
  • Overall Contact(s)
    • Michael Jünger, Prof. Dr., +493834-866770, juenger@uni-greifswald.de

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