Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

Phase 2

• Conditions: Lymphedema
• Interventions: Other: Compression Armsleeves

• Registration Number: NCT01318785
• Lead Sponsor: 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.

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)

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Status Verified: 2011-09
• Study Start: 2011-09
• Last Update Submitted: 2011-09-05
• Last Update Posted: 2011-09-07
• Primary Completion: 2011-10
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression ArmsleevesType A	Compression Armsleeves	Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
Compression Armsleeves Type B	Compression Armsleeves	Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387

Primary Outcome Measures

Name	Time	Method
change of volume (arm and hand together)	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

Name	Time	Method
Clinical judgement of skin status	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	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

Trial Locations

Locations (4)

Landeskrankenhaus Wolfsberg; 🇦🇹 Wolfsberg, Kärnten, Austria

Universitaire Ziekenhuizen; 🇧🇪 Leuven, Belgium

Nij Smellinghe Hosptial; 🇳🇱 Drachten, Netherlands

Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße; 🇩🇪 Greifswald, Mecklenburg Vorpommern, Germany