NCT01318785

Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Lymphedema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-03-18
• Last updated: 2011-09-07

Locations

4 sites across 4 countries: Austria, Belgium, Germany, Netherlands