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

At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)

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.

Study Overview

• Status: Terminated
• Conditions: Lymphedema
• Intervention / Treatment: Device: Flexitouch System; Device: Hydroven FPR

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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Flinders Medical Center
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Gosforth, United Kingdom, NE25 8SU
    • St Oswalds Hospice
  • Kendal, United Kingdom, LA9 4BD
    • Kendal Lymphology Centre
  • Norwich, United Kingdom
    • Norfolk and Norwich University
  • Nottingham, United Kingdom
    • Queens Medical Center
  • Swansea, United Kingdom, SA2 8QA
    • Lymphoedema Clinic, Singleton Hospital
  • Whittington, United Kingdom, WS14 9LH
    • St Giles Hospice
  • Leics
    • Leicester, Leics, United Kingdom, LE3 9QE
      • LOROS Hospice
  • Nottinghamshire
    • Mansfield, Nottinghamshire, United Kingdom
      • King's Mill Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 8LL
      • University of Glasgow
  • West Glamorgan
    • Swansea, West Glamorgan, United Kingdom
      • Abertawe Bro Morgannwg University
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative
  • Missouri
    • Columbia, Missouri, United States, 65203
      • University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
  • New York
    • Stony Brook, New York, United States, 11794-8191
      • Stony Brook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Rehabilitation
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital Systems
  • Vermont
    • Colchester, Vermont, United States, 05446
      • Fletcher Allen Health Care, Inc., University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml	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.	Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent	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.	Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events - Totals	Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial	Up to 24 weeks of treatment

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2010
• Primary Completion (Actual): October 26, 2011
• Study Completion (Actual): June 27, 2012

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: lymphedema; randomised clinical trial; pneumatic compression device; volume reduction
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: Flexitouch 1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO