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Assessment of Unilateral Lymphoedema of the Leg

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ClinicalTrials.gov Identifier: NCT00757406
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : April 16, 2009
Sponsor:
Information provided by:
ImpediMed Limited

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

Condition or disease
Lymphedema

Detailed 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 Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Unilateral Lymphoedema of the Leg
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort
1
Test group - Lymphedema sufferers
2
Control group - healthy volunteers



Primary Outcome Measures :
  1. That the L-Dex U400 detects Unilateral leg lymphedema in subjects with the condition and does not detect it in subjects without the condition. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Group 1 - Test group - will be recruited through advertisements placed at Qld Lymphoedema and Breast Oncology Physiotherapy, Lymphoedema Association of QLD, Gynecological Cancer Support Group and notification to other private therapists to inform them of the study.

Group 2 - Control group - will be through advertisements placed at Qld Lymphoedema and Breast Oncology Physiotherapy.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757406


Locations
Australia, Queensland
Qld Lymphoedema and Breast Oncology Physiotherapy
Brisbane, Queensland, Australia, 4051
Sponsors and Collaborators
ImpediMed Limited
Investigators
Principal Investigator: Robyn C Box, PhD Qld Lymphoedema and Breast Oncology Physiotherapy

Responsible Party: Dr Robyn Box, Queensland Lymphoedema and Breast Oncology Physiotherapy
ClinicalTrials.gov Identifier: NCT00757406     History of Changes
Other Study ID Numbers: UQLDEX02
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: April 2009

Keywords provided by ImpediMed Limited:
Lymphedema
Bioimpedance

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases