Clinical Trial: Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compressi
Brief Summary:
Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
- Assessment of safety
- Quality of life
- Health economic parameters
- Slippage
- Subbandage pressure
Detailed Summary:
Sponsor: 3M
Current Primary Outcome: Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. [ Time Frame: baseline and after 3 weeks of treatment ]
Original Primary Outcome: Volume reduction [ Time Frame: 3 weeks ]
Current Secondary Outcome: Assessment of Safety by Incidence of Adverse Events. [ Time Frame: 3 weeks ]
Original Secondary Outcome: Same as current
Information By: 3M
Dates:
Date Received: March 22, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 26, 2012
Last Verified: November 2012
