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Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Centre for Research & Implementation of Clinical Practice
Sponsor:
Collaborator:
Tactile Technologies Inc.
Information provided by (Responsible Party):
Centre for Research & Implementation of Clinical Practice
ClinicalTrials.gov Identifier:
NCT01239160
First received: November 10, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Lymphedema
Device: Flexitouch System
Device: Hydroven FPR
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Centre for Research & Implementation of Clinical Practice:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 262
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239160

Contacts
Contact: Christine J Moffatt, RGN PhD +44 2073511411 christine.moffatt@cricp.org.uk
Contact: Peter Franks, PhD +44 2073511411 peter.franks@cricp.org.uk

Locations
United States, Arizona
Hope Research Institute Completed
Phoenix, Arizona, United States, 85050
United States, Illinois
Northwestern University Completed
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
Carolinas Rehabilitation Completed
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
Australia
Flinders Medical Center Not yet recruiting
Adelaide, Australia
Contact: Neil Piller, PhD       Neil.Piller@flinders.edu.au   
Principal Investigator: Neil Pillar, PhD         
United Kingdom
LOROS Hospice Completed
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    vaughan.keeley@derbyhospitals.nhs.uk   
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
Sponsors and Collaborators
Centre for Research & Implementation of Clinical Practice
Tactile Technologies Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Centre for Research & Implementation of Clinical Practice
ClinicalTrials.gov Identifier: NCT01239160     History of Changes
Other Study ID Numbers: Flexitouch 1010
Study First Received: November 10, 2010
Last Updated: November 20, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Centre for Research & Implementation of Clinical Practice:
lymphedema
pneumatic compression device
randomised clinical trial
volume reduction

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014