Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE)
The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition.
The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression.
This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)|
- limb volume change after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Limb volume as assessed by tape measure at 4 cm intervals up the limb. Volume calculated by assuming a truncated cone for each section of the limb.
- Adverse events [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: Yes ]Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Advanced PCD
The use of an advanced PCD device to reduce and maintain limb volume
Device: Flexitouch System
A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day
Active Comparator: Simple PCD
The use of the Simple PCD is to reduce and maintain limb volume
Device: Hydroven FPR
The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
This is a Multicentre, prospective, single (assessor) blind randomised study. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs with an advanced PCD compared to a simple PCD in patients with lower limb lymphoedema. The main outcome is the percentage volume reduction of the affected limb at end of treatment compared to baseline.
Secondary objectives of the study are Assessment of safety Quality of life Health economic parameters
In total 262 patients with leg lymphoedema will be enrolled into the study. Patients eligible for the study are those who suffer from late stage II and stage III according to the International Society of Lymphology lymphoedema staging. Lymphoedematous legs can be of primary or secondary origin and uni or bilaterally affected. Medical history will be taken at baseline.
Patients will be taught how to use the device they have been randomised to. Visits will then take place at weeks 1,4,8,12 and 24 weeks. The device will be used for up to 60 minutes each day on the trial limb. At each visit sequential circumferences of the affected and unaffected limbs will be measured with a tape measure.
All adverse events will be documented. At beginning and end of study quality of life questionnaires and health economic information will be completed by the patients.
At the Derby site assessment of tissue quality will be made using ultrasound and moisture meter to assess tissue fluid.
|Contact: Christine J Moffatt, RGN PhD||+44 firstname.lastname@example.org|
|Contact: Peter Franks, PhD||+44 email@example.com|
|United States, Arizona|
|Hope Research Institute||Completed|
|Phoenix, Arizona, United States, 85050|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Prairie Education & Research Cooperative||Completed|
|Springfield, Illinois, United States, 62701|
|United States, Missouri|
|University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic||Completed|
|Columbia, Missouri, United States, 65203|
|United States, New York|
|Stony Brook University Medical Center||Completed|
|Stony Brook, New York, United States, 11794-8191|
|United States, North Carolina|
|Charlotte, North Carolina, United States|
|United States, Ohio|
|Ohio State University Medical Center||Completed|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Completed|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Carolina|
|Greenville Hospital Systems||Completed|
|Greenville, South Carolina, United States, 29615|
|United States, Vermont|
|Fletcher Allen Health Care, Inc., University of Vermont||Completed|
|Colchester, Vermont, United States, 05446|
|Leicester, Leics, United Kingdom, LE3 9QE|
|University of Glasgow||Completed|
|Glasgow, Scotland, United Kingdom, G12 8LL|
|Royal Derby Hospital||Recruiting|
|Derby, United Kingdom, DE22 3NE|
|Contact: Vaughan Keeley, MD +44 1332 783075 firstname.lastname@example.org|
|Principal Investigator: Christine Moffatt, RN PhD|
|Sub-Investigator: Katie Riches, RN|
|St Oswalds Hospice||Completed|
|Gosforth, United Kingdom, NE25 8SU|
|Kendal Lymphology Centre||Completed|
|Kendal, United Kingdom, LA9 4BD|
|Lymphoedema Clinic, Singleton Hospital||Completed|
|Swansea, United Kingdom, SA2 8QA|
|St Giles Hospice||Completed|
|Whittington, United Kingdom, WS14 9LH|
|Study Chair:||Christine J Moffatt, RN PhD||Centre for Research & Implementation of Clinical Practice|
|Study Director:||Vaughan Keeley, MD||Derby Hospitals NHS Trust|
|Principal Investigator:||Margaret Sneddon, RGN||University of Glasgow|
|Principal Investigator:||Peter J Franks, PhD||Centre for Research & Implementation of Clinical Practice|