Status:
COMPLETED
Assessment of Unilateral Lymphoedema of the Leg
Lead Sponsor:
ImpediMed Limited
Conditions:
Lymphedema
Eligibility:
All Genders
18-75 years
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00757406
Start Date
August 1 2008
End Date
January 1 2009
Last Update
April 16 2009
Active Locations (1)
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1
Qld Lymphoedema and Breast Oncology Physiotherapy
Brisbane, Queensland, Australia, 4051