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

Primary Purpose

Lymphedema

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Compression Armsleeves
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring secondary arm-lymphedema, breast cancer related arm-lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Landeskrankenhaus WolfsbergRecruiting
  • Universitaire ZiekenhuizenRecruiting
  • Klinik und Poliklinik für Hautkrankheiten, SauerbruchstraßeRecruiting
  • Nij Smellinghe HosptialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Compression ArmsleevesType A

Compression Armsleeves Type B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
December 3, 2010
Last Updated
September 5, 2011
Sponsor
University Medicine Greifswald
Collaborators
KABEG Management, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01318785
Brief Title
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
Acronym
BF09-PH-01
Official Title
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald
Collaborators
KABEG Management, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase thesis: - all types should be equal regarding volume reduction thesis: armsleeves manufactured with microfibre yarn are expected to be better in wearing comfort and better in handling features.
Detailed Description
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) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
secondary arm-lymphedema, breast cancer related arm-lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compression ArmsleevesType A
Arm Type
Active Comparator
Arm Description
Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
Arm Title
Compression Armsleeves Type B
Arm Type
Active Comparator
Arm Description
Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387
Intervention Type
Other
Intervention Name(s)
Compression Armsleeves
Other Intervention Name(s)
Bauerfeind SoraLife, Jobst Elvarex
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of volume (arm and hand together)
Description
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.
Time Frame
6 weaks per patient
Secondary Outcome Measure Information:
Title
Clinical judgement of skin status
Description
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
Time Frame
6 weaks per patient
Title
Wearing comfort and handling features of armsleeves
Description
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
Time Frame
6 weeks per patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Jünger, Prof. Dr.
Phone
+493834-866770
Email
juenger@uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Eggert, Study Nurse
Phone
+493834-866770
Email
claudia.eggert@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jünger, Prof. Dr.
Organizational Affiliation
Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Wolfsberg
City
Wolfsberg
State/Province
Kärnten
ZIP/Postal Code
9400
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Döller, MD
Email
sekretariatlymph@lkh-wo.at
First Name & Middle Initial & Last Name & Degree
Walter Döller, MD
Facility Name
Universitaire Ziekenhuizen
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Flour, MD
Email
maria.flour@uz.kuleuven.ac.be
First Name & Middle Initial & Last Name & Degree
Maria Flour, MD
Facility Name
Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
City
Greifswald
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jünger, Prof. Dr.
Phone
+493834-866770
Email
juenger@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Claudia Eggert, Study Nurse
Phone
+493834-866770
Email
claudia.eggert@uni-greifswald.de
Facility Name
Nij Smellinghe Hosptial
City
Drachten
ZIP/Postal Code
9202
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Damstra, MD
Email
r.damstra@nijsmellinghe.nl
First Name & Middle Initial & Last Name & Degree
Robert Damstra, MD

12. IPD Sharing Statement

Links:
URL
http://www.medizin.uni-greifswald.de/haut/
Description
link to Greifswald dermatology

Learn more about this trial

Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

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