LymphedemaPhase 2BF09-PH-01NCT01318785
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
A Phase 2 study testing Compression Armsleeves in people with Lymphedema, run by University Medicine Greifswald at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Compression Armsleeves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2011to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Austria1 site, 1 recruiting
- Recruiting
Landeskrankenhaus Wolfsberg
Wolfsberg, Carinthia, 9400
Walter Döller, MD, sekretariatlymph@lkh-wo.at
Walter Döller, MD
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen
Leuven, 3000
Maria Flour, MD, maria.flour@uz.kuleuven.ac.be
Maria Flour, MD
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
Greifswald, Mecklenburg-Vorpommern, 17475
Michael Jünger, Prof. Dr., +493834-866770, juenger@uni-greifswald.de
Claudia Eggert, Study Nurse, +493834-866770, claudia.eggert@uni-greifswald.de
Netherlands1 site, 1 recruiting
- Recruiting
Nij Smellinghe Hosptial
Drachten, 9202
Robert Damstra, MD, r.damstra@nijsmellinghe.nl
Robert Damstra, MD
About this study
Official title: Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
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.
Read the 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)
- Conditions
- Lymphedema
- Being tested
- Compression Armsleeves
- Keywords
- secondary arm-lymphedema, breast cancer related arm-lymphedema
- Medical subject headings
- Lymphedema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression ArmsleevesOther
Also called Bauerfeind SoraLife, Jobst Elvarex
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression ArmsleevesType A | Active comparator | Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387 Receives: Other: Compression Armsleeves |
| Compression Armsleeves Type B | Active comparator | Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387 Receives: Other: Compression Armsleeves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weaks per patient
Secondary outcomes (2)
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
Measured: 6 weaks per patient
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
Measured: 6 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- KABEG Management, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Michael Jünger, Prof. Dr., Principal investigator, Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318785
- Sponsor's protocol ID
- Multicentrestudy "BF09-PH-01"
- Acronym
- BF09-PH-01
- Status last verified
- Sep 2011
- First submitted
- 3 Dec 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
- ClinicalTrials.gov ID
- NCT01318785
- Acronym / sponsor ID
- BF09-PH-01 / Multicentrestudy "BF09-PH-01"
- Conditions
- Lymphedema
- Keywords
- secondary arm-lymphedema, breast cancer related arm-lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- KABEG Management, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen KU Leuven
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression ArmsleevesType A | Active comparator | Other: Compression ArmsleevesProduct A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387 |
| Compression Armsleeves Type B | Active comparator | Other: Compression ArmsleevesProduct B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- edema not completely reduced to "maintenance phase"
- immobilized patient
- acute deep vein thrombosis in arm
- directly after arm-vein-thrombosis
- acute arm erysipelas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression ArmsleevesAlso: Bauerfeind SoraLife, Jobst ElvarexType: 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. | Other | Compression Armsleeves Type B, Compression ArmsleevesType A |
Primary outcome
change of volume (arm and hand together)
Time frame: 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.
2 secondary outcomes
Clinical judgement of skin status
Time frame: 6 weaks per patient
Wearing comfort and handling features of armsleeves
Time frame: 6 weeks per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jünger, Prof. Dr. principal investigator
Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compression Armsleeves in people with Lymphedema, run by University Medicine Greifswald at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Belgium, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Jünger, Prof. Dr. (+493834-866770, juenger@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of volume (arm and hand together) (time frame: 6 weaks per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.