Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE)
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|ClinicalTrials.gov Identifier: NCT01239160|
Recruitment Status : Terminated (Futility and underpowering of endpoint data)
First Posted : November 11, 2010
Results First Posted : October 14, 2020
Last Update Posted : November 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema||Device: Flexitouch System Device: Hydroven FPR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)|
|Actual Study Start Date :||November 2, 2010|
|Actual Primary Completion Date :||October 26, 2011|
|Actual Study Completion Date :||June 27, 2012|
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.
- Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml [ Time Frame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes. ]Limb volume in ml as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.
- Limb Volume Change Baseline to 12 Weeks of Treatment - Percent [ Time Frame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes. ]Limb volume (percent change from baseline) as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.
- Adverse Events - Totals [ Time Frame: Up to 24 weeks of treatment ]Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239160
|Study Chair:||Christine J Moffatt, RN PhD||Nottingham Trent University|
|Study Director:||Vaughan Keeley, MD||Derby Hospitals NHS Trust|
|Principal Investigator:||Margaret Sneddon, RGN||University of Glasgow|
|Principal Investigator:||Peter J Franks, PhD||Tactile Medical|