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

Lymphedema Clinical Trial

Official title: Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

• NCT number: NCT01318785
• Study type: Interventional
• Source: University Medicine Greifswald
• Contact: Michael Jünger, Prof. Dr.
• Phone: +493834-866770
• Email: juenger@uni-greifswald.de
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2011
• Completion date: November 2011