Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

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.
    

Intervention name(s): coban 2 system; coban lite system
Intervention type(s): Device; Device
Intervention description(s): 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; 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
Intervention MeSH terms: Monensin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: leg lymphedema; volume measurement; compression therapy; interface pressure; static stiffness index (SSI); volume change