Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

NCT ID: NCT01239160

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-02
• Study Completion Date: 2012-06-27

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.

Conditions

Lymphedema

Keywords

lymphedema; pneumatic compression device; randomised clinical trial; volume reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Advanced PCD

The use of an advanced PCD device to reduce and maintain limb volume

Group Type: EXPERIMENTAL

Flexitouch System

Intervention Type: DEVICE

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

Simple PCD

The use of the Simple PCD is to reduce and maintain limb volume

Group Type: ACTIVE_COMPARATOR

Hydroven FPR

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tactile Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine J Moffatt, RN PhD

Role: STUDY_CHAIR

Nottingham Trent University

Vaughan Keeley, MD

Role: STUDY_DIRECTOR

Derby Hospitals NHS Trust

Margaret Sneddon, RGN

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Peter J Franks, PhD

Role: PRINCIPAL_INVESTIGATOR

Tactile Medical

Locations

Hope Research Institute

Phoenix, Arizona, United States

Northwestern University

Chicago, Illinois, United States

Prairie Education & Research Cooperative

Springfield, Illinois, United States

University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic

Columbia, Missouri, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Carolinas Rehabilitation

Charlotte, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Greenville Hospital Systems

Greenville, South Carolina, United States

Fletcher Allen Health Care, Inc., University of Vermont

Colchester, Vermont, United States

Flinders Medical Center

Adelaide, , Australia

LOROS Hospice

Leicester, Leics, United Kingdom

King's Mill Hospital

Mansfield, Nottinghamshire, United Kingdom

University of Glasgow

Glasgow, Scotland, United Kingdom

Abertawe Bro Morgannwg University

Swansea, West Glamorgan, United Kingdom

Royal Derby Hospital

Derby, , United Kingdom

St Oswalds Hospice

Gosforth, , United Kingdom

Kendal Lymphology Centre

Kendal, , United Kingdom

Norfolk and Norwich University

Norwich, , United Kingdom

Queens Medical Center

Nottingham, , United Kingdom

Lymphoedema Clinic, Singleton Hospital

Swansea, , United Kingdom

St Giles Hospice

Whittington, , United Kingdom

Countries

United States; Australia; United Kingdom

Other Identifiers

Flexitouch 1010

Identifier Type: -

Identifier Source: org_study_id