LymphedemaNCT01828606
Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema
A study testing coban 2 system and coban lite system in people with Lymphedema, run by Nij Smellinghe Hosptial at 3 sites in 3 countries.
Trial summary
Although there is no doubt about the need for compression therapy in lymphoedema, it is not investigated in much detail how much pressure is needed to get optimum volume reduction. New research suggests that there is obviously an upper pressure limit beyond further increase of pressure seems contra productive. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- coban 2 system and coban lite system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2013to Sep 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mobile males or females, age 18 years or older
- Subject is mobile and able to walk minimum 5000 steps
- Subject has unilateral or bilateral leg lymphoedema of primary or secondary origin
- Maximum leg circumference at C position is 60 cm or less
- Subject has more or equal than 5 mm pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- Subject requires intense bandaging therapy
- ABPI >= 0.8
- Willing to give written informed consent and willing to comply with the study protocol
Who cannot join
- Known pregnancy
- Evidence of active cancer with potential or known risk of metastasis
- Cancer treatments (surgery, chemotherapy, radiotherapy) not completed at least 6 months prior to randomisation
- Lobes, that a proper bandage application is not possible
- Lobes in the area where a pressure sensor needs to be placed
- A period of intense daily bandaging within the last month
Show all 14Show fewer
- Any oedema not directly related to lymph failure (e.g. related to heart, renal disease etc.)
- Diuretic treatments
- Paralysis or neuropathy of the legs
- Clinical infection of the legs (e.g. erysipelas)
- Postthrombotic syndrome and/or medical conditions that are contraindicated for compression therapy
- History of allergic reactions to study material
- Participation in any other prospective clinical study that can potentially interfere with this study
- Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Denmark1 site
Dermato-venerologisk afd. og videncenter for sårheling D/S Bispebjerg Hospital
København NV, DK 2400
Netherlands1 site
Nij Smellinghe hospital
Drachten, Provincie Friesland, 9202NN
About this study
Official title: Randomised Controlled Trial to Compare the Influence of Sub-bandage Pressure on Percentage Volume Reduction of Leg Lymphoedema
Although there is no doubt about the need for compression therapy in lymphoedema, it is not investigated in much detail how much pressure is needed to get optimum volume reduction. New research suggests that there is obviously an upper pressure limit beyond further increase of pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity. This study is designed to investigate the effect of pressure on %volume reduction of leg lymphoedema with 2 bandages which are very comparable in product properties (slippage, stiffness, etc.), but differ in their pressure exerted to the limb.
Read the detailed description
Lymphoedema is a chronic swelling caused by the regional accumulation of protein-rich fluid in tissues due to a compromised lymphatic system. This may present as primary lymphoedema, defined as congenital abnormality of lymphatic vessels or secondary lymphoedema, acquired from various insults to the lymphatic system, such as malignancy, trauma, surgery or irradiation. It is most frequently seen after lymph node dissection, surgery or radiation therapy during cancer treatment, most notably breast cancer. In the United Kingdom a large prevalence study was undertaken by Moffatt et al and a rate of 1.33 per 1000 population was identified. In general, the prevalence increases with age and is higher in women than in men. One function of the lymphatic system is to remove fluid from the interstitial tissues and return it to the venous circulation. compression therapy is the cornerstone in the treatment of lymphoedema
Much of evidence how compression works is based on research in venous disease, which has been extrapolated to lymphoedema. Hence, compression bandaging systems available in the market are used for the treatment of venous disease and at the same time lymphoedema.
This upper limit is around 30-40 mm Hg of initial pressure exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity. This is also stated in the International Lymphoedema Framework position document "Compression Therapy: A position document on compression bandaging".
100 subjects with leg lymphoedema will be enrolled into the study. The duration of study will be one week for each participant. All participants will receive compression therapy with 3M Coban 2 and 3M Coban 2 Lite respectively according to the randomisation list. The goal of the present study is to gain information on %volume reduction of lymphoedematous legs in relation to pressure.
- Conditions
- Lymphedema
- Being tested
- coban 2 system, coban lite system
- Keywords
- leg lymphedema, volume measurement, compression therapy, interface pressure, static stiffness index (SSI), volume change
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coban 2 systemDevice
All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment
According to protocol the materials are applied to the whole leg and the measuring devices are put in place
coban lite systemDevice
All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment
According to protocol the materials are applied to the whole leg and the measuring devices are put in place
| Study group | Role | What they receive |
|---|---|---|
| Coban 2 system | Experimental | The two layer system is more stiff and the material is different designed Receives: Device: coban 2 system; Device: coban lite system |
| coban lite systems | Experimental | All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment
According to protocol the materials are applied to the whole leg and the measuring devices are put in place Receives: Device: coban 2 system; Device: coban lite system |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume decrease in relation to pressure application of two types of bandages
At each of the 8 visits the supine and standing pressure under the bandage is measured with a Picopress device at the B1, C and F positions. The patient will receive new bandaging twice a week. At those visits the volume is determined and a second pressure measurement is conducted 2 hours after bandage application. For safety assessment all adverse events will be documented.
The total number of bandage changes could increase if bandage changes are required more often. On these occasions all measurements, which are required on a regular bandage change day, will be performed.
Measured: 1 week, 2 bandages changes
Secondary outcomes (1)
pressure drop profiles under 2 bandage types
At each of the 8 visits the supine and standing pressure under the bandage is measured with a Picopress device at the B1, C and F positions. The patient will receive new bandaging twice a week. At those visits the volume is determined and a second pressure measurement is conducted 2 hours after bandage application. For safety assessment all adverse events will be documented.
The total number of bandage changes could increase if bandage changes are required more often. On these occasions all measurements, which are required on a regular bandage change day, will be performed.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionSep 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nij Smellinghe Hosptial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Damstra, Nij Smellinghe Hosptial
- Investigators
- RJ Damstra, MD PhD, Principal investigator, Nij smellinghe hospital, NetherlandsFJ Schingale, MD PhD, Principal investigator, Lympho-Opt GmbH, GermanyH Partsch, MD PhD, Study chair, professor with eremite, AustriaT Karlsmark, MD PhD, Principal investigator, Bispebjerg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828606
- Sponsor's protocol ID
- NS6NL
- Other IDs
- CLIN-PROT-EU-05-184776
- Status last verified
- Feb 2014
- First submitted
- 7 Apr 2013
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Compare the Influence of Sub-bandage Pressure on Percentage Volume Reduction of Leg Lymphoedema
- ClinicalTrials.gov ID
- NCT01828606
- Acronym / sponsor ID
- NS6NL
- Conditions
- Lymphedema
- Keywords
- leg lymphedema, volume measurement, compression therapy, interface pressure, static stiffness index (SSI), volume change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Apr 2013 (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.
Although there is no doubt about the need for compression therapy in lymphoedema, it is not investigated in much detail how much pressure is needed to get optimum volume reduction. New research suggests that there is obviously an upper pressure limit beyond further increase of pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity. This study is designed to investigate the effect of pressure on %volume reduction of leg lymphoedema with 2 bandages which are very comparable in product properties (slippage, stiffness, etc.), but differ in their pressure exerted to the limb.
Detailed description
Lymphoedema is a chronic swelling caused by the regional accumulation of protein-rich fluid in tissues due to a compromised lymphatic system. This may present as primary lymphoedema, defined as congenital abnormality of lymphatic vessels or secondary lymphoedema, acquired from various insults to the lymphatic system, such as malignancy, trauma, surgery or irradiation. It is most frequently seen after lymph node dissection, surgery or radiation therapy during cancer treatment, most notably breast cancer. In the United Kingdom a large prevalence study was undertaken by Moffatt et al and a rate of 1.33 per 1000 population was identified. In general, the prevalence increases with age and is higher in women than in men. One function of the lymphatic system is to remove fluid from the interstitial tissues and return it to the venous circulation. compression therapy is the cornerstone in the treatment of lymphoedema
Much of evidence how compression works is based on research in venous disease, which has been extrapolated to lymphoedema. Hence, compression bandaging systems available in the market are used for the treatment of venous disease and at the same time lymphoedema.
This upper limit is around 30-40 mm Hg of initial pressure exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity. This is also stated in the International Lymphoedema Framework position document "Compression Therapy: A position document on compression bandaging".
100 subjects with leg lymphoedema will be enrolled into the study. The duration of study will be one week for each participant. All participants will receive compression therapy with 3M Coban 2 and 3M Coban 2 Lite respectively according to the randomisation list. The goal of the present study is to gain information on %volume reduction of lymphoedematous legs in relation to pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coban 2 system | Experimental | Device: coban 2 system, Device: coban lite systemThe two layer system is more stiff and the material is different designed |
| coban lite systems | Experimental | Device: coban 2 system, Device: coban lite systemAll centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment According to protocol the materials are applied to the whole leg and the measuring devices are put in place |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mobile males or females, age 18 years or older
- Subject is mobile and able to walk minimum 5000 steps
- Subject has unilateral or bilateral leg lymphoedema of primary or secondary origin
- Maximum leg circumference at C position is 60 cm or less
- Subject has more or equal than 5 mm pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
Key exclusion criteria (14 listed)
- Known pregnancy
- Evidence of active cancer with potential or known risk of metastasis
- Cancer treatments (surgery, chemotherapy, radiotherapy) not completed at least 6 months prior to randomisation
- Lobes, that a proper bandage application is not possible
- Lobes in the area where a pressure sensor needs to be placed
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 |
|---|---|---|
| coban 2 systemAll centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment According to protocol the materials are applied to the whole leg and the measuring devices are put in place | Device | Coban 2 system, coban lite systems |
| coban lite systemAll centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment According to protocol the materials are applied to the whole leg and the measuring devices are put in place | Device | Coban 2 system, coban lite systems |
Primary outcome
volume decrease in relation to pressure application of two types of bandages
Time frame: 1 week, 2 bandages changes
At each of the 8 visits the supine and standing pressure under the bandage is measured with a Picopress device at the B1, C and F positions. The patient will receive new bandaging twice a week. At those visits the volume is determined and a second pressure measurement is conducted 2 hours after bandage application. For safety assessment all adverse events will be documented. The total number of bandage changes could increase if bandage changes are required more often. On these occasions all measurements, which are required on a regular bandage change day, will be performed.
1 secondary outcome
pressure drop profiles under 2 bandage types
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- The foundation related to the expert centre organizing researchLink provided by the sponsor.
- General website form the Nij Smellinghe hospitalLink provided by the sponsor.
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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.
RJ Damstra, MD PhD principal investigator
Nij smellinghe hospital, Netherlands
FJ Schingale, MD PhD principal investigator
Lympho-Opt GmbH, Germany
H Partsch, MD PhD study chair
professor with eremite, Austria
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coban 2 system and coban lite system in people with Lymphedema, run by Nij Smellinghe Hosptial at 3 sites in 3 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume decrease in relation to pressure application of two types of bandages (time frame: 1 week, 2 bandages changes). 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 10 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.