Clinical Trial on Lymphedema - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Queensland
  - Brisbane, Queensland, Australia, 4051
    - Qld Lymphoedema and Breast Oncology Physiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImpediMed Limited

Investigators

Principal Investigator: Robyn C Box, PhD, Qld Lymphoedema and Breast Oncology Physiotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 21, 2008

First Submitted That Met QC Criteria