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Trial record 10 of 62 for:    Open Studies | "Lymphedema"

Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nij Smellinghe Hosptial
Sponsor:
Information provided by (Responsible Party):
R.J. Damstra, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier:
NCT01828606
First received: April 7, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Lymphedema
Device: coban 2 system
Device: coban lite system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Compare the Influence of Sub-bandage Pressure on Percentage Volume Reduction of Leg Lymphoedema

Resource links provided by NLM:


Further study details as provided by Nij Smellinghe Hosptial:

Primary Outcome Measures:
  • volume decrease in relation to pressure application of two types of bandages [ Time Frame: 1 week, 2 bandages changes ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • pressure drop profiles under 2 bandage types [ Time Frame: 1 week ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coban 2 system
The two layer system is more stiff and the material is different designed
Device: coban 2 system

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

Device: coban lite system

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

Experimental: coban lite systems

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

Device: coban 2 system

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

Device: coban lite system

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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mobile males or females, age 18 years or older
  2. Subject is mobile and able to walk minimum 5000 steps
  3. Subject has unilateral or bilateral leg lymphoedema of primary or secondary origin
  4. Maximum leg circumference at C position is 60 cm or less
  5. 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
  6. Subject requires intense bandaging therapy
  7. ABPI >= 0.8
  8. Willing to give written informed consent and willing to comply with the study protocol

Exclusion Criteria:

  1. Known pregnancy
  2. Evidence of active cancer with potential or known risk of metastasis
  3. Cancer treatments (surgery, chemotherapy, radiotherapy) not completed at least 6 months prior to randomisation
  4. Lobes, that a proper bandage application is not possible
  5. Lobes in the area where a pressure sensor needs to be placed
  6. A period of intense daily bandaging within the last month
  7. Any oedema not directly related to lymph failure (e.g. related to heart, renal disease etc.)
  8. Diuretic treatments
  9. Paralysis or neuropathy of the legs
  10. Clinical infection of the legs (e.g. erysipelas)
  11. Postthrombotic syndrome and/or medical conditions that are contraindicated for compression therapy
  12. History of allergic reactions to study material
  13. Participation in any other prospective clinical study that can potentially interfere with this study
  14. Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828606

Locations
Denmark
Dermato-venerologisk afd. og videncenter for sårheling D/S Bispebjerg Hospital Recruiting
København NV, Denmark, DK 2400
Contact: T Karlsmark, MD PhD    +45 35 31 60 20    Tonny.Karlsmark@regionh.dk   
Principal Investigator: Tonny Karlsmark, MD PhD         
Germany
Lympho-Opt GmbH Recruiting
Pommelsbrunn, Germany, 91224
Contact: F-J Schingale, MD PhD    +49 9154 - 911 200    franz-josef.schingale@lympho-opt.de   
Principal Investigator: F-J Schingale, MD PhD         
Netherlands
Nij Smellinghe hospital Recruiting
Drachten, Friesland, Netherlands, 9202NN
Contact: RJ Damstra, MD PhD    31-51-258-8215    r.damstra@nijsmellinghe.nl   
Contact: Irene Zonderland    31-51-258-8215    i.zonderland@nijsmellinghe.nl   
Principal Investigator: RJ Damstra, MD PhD         
Sub-Investigator: C Bearda Bakker-wensveen, MD         
Sponsors and Collaborators
Nij Smellinghe Hosptial
Investigators
Principal Investigator: RJ Damstra, MD PhD Nij smellinghe hospital, Netherlands
Principal Investigator: FJ Schingale, MD PhD Lympho-Opt GmbH, Germany
Study Chair: H Partsch, MD PhD professor with eremite, Austria
Principal Investigator: T Karlsmark, MD PhD Bispebjerg Hospital, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: R.J. Damstra, MD PhD, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier: NCT01828606     History of Changes
Other Study ID Numbers: NS6NL, CLIN-PROT-EU-05-184776
Study First Received: April 7, 2013
Last Updated: February 11, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: The Bavarian State Ministry of the Environment and Public Health
Denmark: Ethics Committee

Keywords provided by Nij Smellinghe Hosptial:
leg lymphedema
volume measurement
compression therapy
interface pressure
static stiffness index (SSI)
volume change

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Monensin
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Coccidiostats
Enzyme Inhibitors
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Ionophores
Sodium Ionophores
Therapeutic Uses
Uncoupling Agents

ClinicalTrials.gov processed this record on November 27, 2014