Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

Lymphedema Clinical Trial

— BF09-PH-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01318785
• Other study ID #: Multicentrestudy "BF09-PH-01"
• 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

• Lymphedema

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

External Links

•   link to Greifswald dermatology