Clinical trial NCT01239160: Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Official title: At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphedema
Keywords: lymphedema
pneumatic compression device
randomised clinical trial
volume reduction
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be ≥ 18 years old or legal age in host country.
* Subjects must have a diagnosis of primary or secondary late Stage 2 or 3 unilateral or bilateral lower extremity lymphoedema.
* At time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable.
* If subjects were treated in a clinic setting for lymphoedema (Phase 1 treatment) they must be at least 3 months post completion of their acute care.

Exclusion Criteria:

* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.
* Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.
* Diagnosis of acute thrombophlebitis (in last 2 months)
* Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower.
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled)
* Diagnosis of chronic kidney disease with a Glomerular Filtration Rate (GFR) of less than 30 mls per minute.
* Patients with poorly controlled asthma (i.e. those with severe persistent symptoms throughout the day, night time awakenings several times per week, use of a beta2 agonist inhaler several times per day and those whose normal activity is extremely limited).
* Pregnancy
* Any condition where increased venous and lymphatic return is undesirable
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Currently participating in another clinical trial

Primary outcomes:
measure: Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml
timeFrame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
measure: Limb Volume Change Baseline to 12 Weeks of Treatment - Percent
timeFrame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Secondary outcomes:
measure: Adverse Events - Totals
timeFrame: Up to 24 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Columbia
country: United States
facility: University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital Systems
state: South Carolina
city: Colchester
country: United States
facility: Fletcher Allen Health Care, Inc., University of Vermont
state: Vermont
city: Adelaide
country: Australia
facility: Flinders Medical Center
city: Leicester
country: United Kingdom
facility: LOROS Hospice
state: Leics
city: Mansfield
country: United Kingdom
facility: King's Mill Hospital
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Scotland
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University
state: West Glamorgan
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Gosforth
country: United Kingdom
facility: St Oswalds Hospice
city: Kendal
country: United Kingdom
facility: Kendal Lymphology Centre
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University
city: Nottingham
country: United Kingdom
facility: Queens Medical Center
city: Swansea
country: United Kingdom
facility: Lymphoedema Clinic, Singleton Hospital
city: Whittington
country: United Kingdom
facility: St Giles Hospice
Study officials:
affiliation: Nottingham Trent University
name: Christine J Moffatt, RN PhD
role: STUDY_CHAIR
affiliation: Derby Hospitals NHS Trust
name: Vaughan Keeley, MD
role: STUDY_DIRECTOR
affiliation: University of Glasgow
name: Margaret Sneddon, RGN
role: PRINCIPAL_INVESTIGATOR
affiliation: Tactile Medical
name: Peter J Franks, PhD
role: PRINCIPAL_INVESTIGATOR
References: