Assessment of Unilateral Lymphoedema of the Leg
Summary
To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the leg using the same principles for arms.
Description
When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of the tissues. This results in an overall increase in the total amount of extracellular fluid (ECF) in the limb, causing swelling. This can be documented by measuring the impedance (opposition) to a low frequency current that has been passed into the limb. Low frequency current travels predominantly through the ECF, where the Lymphoedema manifests. As the fluid builds up in the limb, the impedance to the current decreases and it is in this way that low frequency bioimpedance is able to assess Lymphoedema.
Multi-frequency bio-impedance analysis otherwise known as Bioimpedance Spectroscopy (BIS) has been reported to be effective for the measurement of ECF and sub clinical changes in ECF to predict the onset of Lymphoedema in the arms in studies conducted by Cornish et al. It has been reported by Warren et al that BIS can be used as a reliable and accurate tool for documenting presence of lymphoedema in patients with wither upper- or lower-extremity swelling.
The L-Dex U400 device uses an "impedance ratio" methodology to assess unilateral Lymphoedema of the arm. By this method the unaffected arm acts as an internal and subject specific control. The strategy of this study is to show that the L-Dex U400 can use this methodology to assess unilateral leg Lymphoedema.
Study Design
Observational Model: Case Control, Time Perspective: Cross-Sectional
Conditions
Lymphedema
Location
Qld Lymphoedema and Breast Oncology Physiotherapy
Brisbane
Queensland
Australia
4051
Status
Completed
Source
ImpediMed Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00757406
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lymphangiosarcoma
A malignant tumor originating from the endothelial cells of lymphatic vessels. Most lymphangiosarcomas arise in an arm secondary to radical mastectomy but they sometimes complicate idiopathic lymphedema. The lymphedema has usually been present for 6 to 10 years before malignant changes develop. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1866)
Lymphedema
Edema due to obstruction of lymph vessels or disorders of the lymph nodes.
Yellow Nail Syndrome
A rare condition characterized by the presence of yellow nails, LYMPHEDEMA, and/or PLEURAL EFFUSION with respiratory tract involvement. Abnormal lymphatic network may play a role in its etiology. Occasionally inherited, yellow nail syndrome mostly is sporadic without apparent family history.
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