Assessment of Unilateral Lymphoedema of the Leg

NCT00757406 | Completed DMC

• 1 other identifier: UQLDEX02
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

Lymphedema; Bioimpedance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

Test group - Lymphedema sufferers

2

Control group - healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImpediMed Limited: lead

Study Sites (1)

Qld Lymphoedema and Breast Oncology Physiotherapy

Brisbane, Queensland, 4051, Australia

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Robyn C Box, PhD

  Qld Lymphoedema and Breast Oncology Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2008
• First Posted: September 23, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 16, 2009

Record last verified: 2009-04

Locations

AU (1)