At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)
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
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
limb volume change after 12 weeks of treatment
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.
Christine J Moffatt, RN PhD
Centre for Research & Implementation of Clinical Practice
United Kingdom: Medicines and Healthcare Products Regulatory Agency
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Northwestern University||Chicago, Illinois 60611|
|Ohio State University Medical Center||Columbus, Ohio 43210|
|Stony Brook University Medical Center||Stony Brook, New York 11794|
|Hope Research Institute||Phoenix, Arizona|
|Greenville Hospital Systems||Greenville, South Carolina|
|Prairie Education & Research Cooperative||Springfield, Illinois 62701|
|University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic||Columbia, Missouri 65203|
|Carolinas Rehabilitation||Charlotte, North Carolina|
|Fletcher Allen Health Care, Inc., University of Vermont||Colchester, Vermont 05446|