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

University Medicine Greifswald

Status and phase: Unknown; Phase 2

Conditions: Lymphedema

Treatments: Other: Compression Armsleeves

Study type: Interventional

Funder types: Other

Identifiers

NCT01318785

Multicentrestudy "BF09-PH-01"

Details and patient eligibility

About

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 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)

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Compression ArmsleevesType A

Active Comparator group

Description:

Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387

Treatment:

Other: Compression Armsleeves

Compression Armsleeves Type B

Active Comparator group

Description:

Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387

Treatment:

Other: Compression Armsleeves