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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00757406




Registration number
NCT00757406
Ethics application status
Date submitted
21/09/2008
Date registered
23/09/2008
Date last updated
16/04/2009

Titles & IDs
Public title
Assessment of Unilateral Lymphoedema of the Leg
Scientific title
Assessment of Unilateral Lymphoedema of the Leg
Secondary ID [1] 0 0
UQLDEX02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Test group - Lymphedema sufferers

2 - Control group - healthy volunteers
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
That the L-Dex U400 detects Unilateral leg lymphedema in subjects with the condition and does not detect it in subjects without the condition.
Timepoint [1] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Qld Lymphoedema and Breast Oncology Physiotherapy - Brisbane
Recruitment postcode(s) [1] 0 0
4051 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImpediMed Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00757406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn C Box, PhD
Address 0 0
Qld Lymphoedema and Breast Oncology Physiotherapy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00757406