Assessment of Unilateral Lymphoedema of the Leg

Lymphedema Clinical Trial

Official title:

Assessment of Unilateral Lymphoedema of the Leg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757406
• Other study ID #: UQLDEX02
• Status: Completed
• Phase: N/A
• First received: September 21, 2008
• Last updated: April 14, 2009
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: ImpediMed Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lymphedema

Locations

Country	Name	City	State
Australia	Qld Lymphoedema and Breast Oncology Physiotherapy	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
ImpediMed Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	That the L-Dex U400 detects Unilateral leg lymphedema in subjects with the condition and does not detect it in subjects without the condition.		6 months	No