Assessment of Unilateral Lymphoedema of the Leg - Full Text View

Sponsored by:	ImpediMed Limited
Information provided by:	ImpediMed Limited
ClinicalTrials.gov Identifier:	NCT00757406

Purpose

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

Condition
Lymphedema

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Lymphedema

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Assessment of Unilateral Lymphoedema of the Leg

Further study details as provided by ImpediMed Limited:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	45
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Test group - Lymphedema sufferers
2 Control group - healthy volunteers

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757406

Contacts

Contact: Robyn C Box, PhD

+61 7 3356 7737

qlbop@bigpond.com

Locations

Australia, Queensland
Qld Lymphoedema and Breast Oncology Physiotherapy	Recruiting
Brisbane, Queensland, Australia, 4051
Contact: Robyn C Box, PhD +61 7 3356 7737 qlbop@bigpond.com
Principal Investigator: Robyn C Box, PhD

Sponsors and Collaborators

ImpediMed Limited

Investigators

Principal Investigator:

Robyn C Box, PhD

Qld Lymphoedema and Breast Oncology Physiotherapy

More Information

Responsible Party:	Queensland Lymphoedema and Breast Oncology Physiotherapy ( Dr Robyn Box )
Study ID Numbers:	UQLDEX02
Study First Received:	September 21, 2008
Last Updated:	September 21, 2008
ClinicalTrials.gov Identifier:	NCT00757406
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by ImpediMed Limited:

Lymphedema
Bioimpedance

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009