NCT01828606

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

Randomised Controlled Trial to Compare the Influence of Sub-bandage Pressure on Percentage Volume Reduction of Leg Lymphoedema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nij Smellinghe Hosptial · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2013-04-10
• Last updated: 2015-02-10

Locations

3 sites across 3 countries: Denmark, Germany, Netherlands