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Sponsored by: |
ImpediMed Limited |
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Information provided by: | ImpediMed Limited |
ClinicalTrials.gov Identifier: | NCT00757406 |
To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the leg using the same principles for arms.
Condition |
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Lymphedema |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Assessment of Unilateral Lymphoedema of the Leg |
Estimated Enrollment: | 45 |
Study Start Date: | August 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Test group - Lymphedema sufferers
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2
Control group - healthy volunteers
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Group 1:
Group 2:
Exclusion Criteria:
Australia, Queensland | |
Qld Lymphoedema and Breast Oncology Physiotherapy | |
Brisbane, Queensland, Australia, 4051 |
Principal Investigator: | Robyn C Box, PhD | Qld Lymphoedema and Breast Oncology Physiotherapy |
Responsible Party: | Queensland Lymphoedema and Breast Oncology Physiotherapy ( Dr Robyn Box ) |
Study ID Numbers: | UQLDEX02 |
Study First Received: | September 21, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00757406 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Lymphedema Bioimpedance |
Lymphedema Lymphatic Diseases |
Lymphedema Lymphatic Diseases |