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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01239160




Registration number
NCT01239160
Ethics application status
Date submitted
10/11/2010
Date registered
11/11/2010
Date last updated
6/11/2020

Titles & IDs
Public title
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Scientific title
At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)
Secondary ID [1] 0 0
Flexitouch 1010
Universal Trial Number (UTN)
Trial acronym
ACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Flexitouch System
Treatment: Devices - Hydroven FPR

Experimental: Advanced PCD - The use of an advanced PCD device to reduce and maintain limb volume

Active Comparator: Simple PCD - The use of the Simple PCD is to reduce and maintain limb volume


Treatment: Devices: 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

Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml
Timepoint [1] 0 0
Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Primary outcome [2] 0 0
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent
Timepoint [2] 0 0
Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Secondary outcome [1] 0 0
Adverse Events - Totals
Timepoint [1] 0 0
Up to 24 weeks of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2012
Sample size
Target
Accrual to date
Final
238
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Vermont
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Leics
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Nottinghamshire
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Scotland
Country [13] 0 0
United Kingdom
State/province [13] 0 0
West Glamorgan
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Derby
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Gosforth
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Kendal
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Norwich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Nottingham
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Swansea
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Whittington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tactile Medical
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01239160
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christine J Moffatt, RN PhD
Address 0 0
Nottingham Trent University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01239160