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

• ClinicalTrials.gov Identifier: NCT01828606
• Recruitment Status: Completed
• First Posted: April 10, 2013
• Last Update Posted: February 10, 2015
• Sponsor: Nij Smellinghe Hosptial
• Information provided by (Responsible Party): R.J. Damstra, Nij Smellinghe Hosptial

Tracking Information

• First Submitted Date: April 7, 2013
• First Posted Date: April 10, 2013
• Last Update Posted Date: February 10, 2015
• Study Start Date: April 2013
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2013)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 9, 2013)

pressure drop profiles under 2 bandage types [ Time Frame: 1 week ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema
• Official Title: Randomised Controlled Trial to Compare the Influence of Sub-bandage Pressure on Percentage Volume Reduction of Leg Lymphoedema
• Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphedema

Intervention

• 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

Study Arms

• Experimental: Coban 2 system
  The two layer system is more stiff and the material is different designed
  Interventions:

  • Device: coban 2 system
  • Device: coban lite system
• 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

  Interventions:

  • Device: coban 2 system
  • Device: coban lite system

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2015): 60
• Original Estimated Enrollment (submitted: April 9, 2013): 100
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Germany, Netherlands

Administrative Information

• NCT Number: NCT01828606
• Other Study ID Numbers: NS6NL; CLIN-PROT-EU-05-184776 ( Other Grant/Funding Number: 3M Deutschland GmbH )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: R.J. Damstra, Nij Smellinghe Hosptial
• Study Sponsor: Nij Smellinghe Hosptial
• Collaborators: Not Provided

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

• PRS Account: Nij Smellinghe Hosptial
• Verification Date: February 2014