Assessment of Unilateral Lymphoedema of the Leg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

Brief Summary

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To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the leg using the same principles for arms.

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Detailed Description

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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.

Conditions

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Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Test group - Lymphedema sufferers

No interventions assigned to this group

2

Control group - healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Group 1:

* Be between the ages of 18-75 years.
* Self-describe general health as satisfactory.
* Understand the proposed study and be willing and fully able to comply with the study procedures.
* Be a willing participant and be capable of giving and has given informed written consent for entry into the study.
* Have been previously diagnosed, by current clinical practice, as having unilateral Lymphoedema of the leg.

Group 2:

* Be between the ages of 18-75 years.
* Self-describe general health as satisfactory.
* Understand the proposed study and be willing and fully able to comply with the study procedures.
* Be a willing participant and be capable of giving and has given informed written consent for entry into the study.

Exclusion Criteria

* Have a known heart condition or an implantable device such as a pacemaker or ICD.
* Have a metallic surgical implant (e.g. total hip replacement) not including small implants such as sternal wires or surgical staples.
* Suffer from a renal disorder.
* Be taking diuretic medications.
* Have consumed large amounts of alcohol or caffeinated beverages within six hours of the study.
* Have undertaken excessive exercise within two hours of BIA
* Have a reported fever of \> 38°C at time of screening.
* Be currently in the fourth week of the menstrual cycle.
* Be pregnant or currently breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes