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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01318785
Other study ID # Multicentrestudy "BF09-PH-01"
Secondary ID
Status Recruiting
Phase Phase 2
First received December 3, 2010
Last updated September 5, 2011
Start date September 2011
Est. completion date November 2011

Study information

Verified date September 2011
Source University Medicine Greifswald
Contact Michael Jünger, Prof. Dr.
Phone +493834-866770
Email juenger@uni-greifswald.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Landeskrankenhaus Wolfsberg Wolfsberg Kärnten
Belgium Universitaire Ziekenhuizen Leuven
Germany Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße Greifswald Mecklenburg Vorpommern
Netherlands Nij Smellinghe Hosptial Drachten

Sponsors (4)

Lead Sponsor Collaborator
University Medicine Greifswald Landeskrankenhaus Wolfsberg, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of volume (arm and hand together) 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.
6 weaks per patient No
Secondary Clinical judgement of skin status 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 6 weaks per patient No
Secondary Wearing comfort and handling features of armsleeves 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
6 weeks per patient No
See also
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Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
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