Flexitouch dosing systematic evaluation (FlexDose)
Research type
Research Study
Full title
Physiologic responses to varying lymphoedema compression programs with the Flexitouch Systems
IRAS ID
123200
Contact name
Vaughan Keeley
Contact email
Sponsor organisation
Tactile Systems Technology Inc.
Research summary
This study has been designed to evaluate the treatment of lower limb lymphoedema using intermittent pneumatic compression (IPC). Lymphoedema is a chronic condition that arises when the lymph system is impaired and results in swelling to the area(s) affected. Most commonly lymphoedema affects one or both legs. It is a chronic condition that cannot be cured but can be alleviated by appropriate treatment. The aims of treatment include to enhance the flow of lymph and reduce the swelling. The treatment of lymphoedema includes a combination of compression, by bandaging or garments, exercise, skin care and massage. IPC is one method that is used to provide massaging treatment to the affected limb. This consists of an inflatable garment that is applied to the limb and attached to an air compression pump. The inflatable garment is made up of small cuffs or chambers that inflate and deflate to provide the massaging effect.
Previous research studies have been undertaken that demonstrate the benefit of IPC when used in conjunction with other treatments for lymphoedema, however, the optimal time (or dose) for each treatment has not been studied. Previous research and current practice advocate using IPC for between 30 minutes and 2 hours per treatment. IPC treatments are recommended daily and this difference in IPC treatment time may have a significant impact on whether an individual can complete it. This study aims to compare 3 treatment times (doses) of IPC undertaken daily for either 5 or 12 continuous days. Assessments of the treated and non-treated limb will be undertaken before and after each treatment in an attempt to ascertain the most effective treatment dose for people with lower limb lymphoedema.
This study is funded by Tactile Systems, an American company who produce an IPC device that will be used in this study.REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0245
Date of REC Opinion
31 Jul 2013
REC opinion
Further Information Favourable Opinion