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

Primary Purpose

Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Flexitouch System
Hydroven FPR
Sponsored by
Tactile Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring lymphedema, pneumatic compression device, randomised clinical trial, volume reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Research Institute
  • Northwestern University
  • Prairie Education & Research Cooperative
  • University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
  • Stony Brook University Medical Center
  • Carolinas Rehabilitation
  • Ohio State University Medical Center
  • University of Pittsburgh Medical Center
  • Greenville Hospital Systems
  • Fletcher Allen Health Care, Inc., University of Vermont
  • Flinders Medical Center
  • LOROS Hospice
  • King's Mill Hospital
  • University of Glasgow
  • Abertawe Bro Morgannwg University
  • Royal Derby Hospital
  • St Oswalds Hospice
  • Kendal Lymphology Centre
  • Norfolk and Norwich University
  • Queens Medical Center
  • Lymphoedema Clinic, Singleton Hospital
  • St Giles Hospice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Advanced PCD

Simple PCD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Adverse Events - Totals
Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial

Full Information

First Posted
November 10, 2010
Last Updated
October 13, 2020
Sponsor
Tactile Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01239160
Brief Title
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Acronym
ACE
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Futility and underpowering of endpoint data
Study Start Date
November 2, 2010 (Actual)
Primary Completion Date
October 26, 2011 (Actual)
Study Completion Date
June 27, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
lymphedema, pneumatic compression device, randomised clinical trial, volume reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced PCD
Arm Type
Experimental
Arm Description
The use of an advanced PCD device to reduce and maintain limb volume
Arm Title
Simple PCD
Arm Type
Active Comparator
Arm Description
The use of the Simple PCD is to reduce and maintain limb volume
Intervention Type
Device
Intervention Name(s)
Flexitouch System
Intervention Description
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
Intervention Name(s)
Hydroven FPR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml
Description
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.
Time Frame
Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Title
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent
Description
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.
Time Frame
Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Secondary Outcome Measure Information:
Title
Adverse Events - Totals
Description
Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial
Time Frame
Up to 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine J Moffatt, RN PhD
Organizational Affiliation
Nottingham Trent University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vaughan Keeley, MD
Organizational Affiliation
Derby Hospitals NHS Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Margaret Sneddon, RGN
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J Franks, PhD
Organizational Affiliation
Tactile Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Greenville Hospital Systems
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Fletcher Allen Health Care, Inc., University of Vermont
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Flinders Medical Center
City
Adelaide
Country
Australia
Facility Name
LOROS Hospice
City
Leicester
State/Province
Leics
ZIP/Postal Code
LE3 9QE
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Mansfield
State/Province
Nottinghamshire
Country
United Kingdom
Facility Name
University of Glasgow
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 8LL
Country
United Kingdom
Facility Name
Abertawe Bro Morgannwg University
City
Swansea
State/Province
West Glamorgan
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
St Oswalds Hospice
City
Gosforth
ZIP/Postal Code
NE25 8SU
Country
United Kingdom
Facility Name
Kendal Lymphology Centre
City
Kendal
ZIP/Postal Code
LA9 4BD
Country
United Kingdom
Facility Name
Norfolk and Norwich University
City
Norwich
Country
United Kingdom
Facility Name
Queens Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
Lymphoedema Clinic, Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
St Giles Hospice
City
Whittington
ZIP/Postal Code
WS14 9LH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

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