Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01239160
Ethics application status
Date submitted
10/11/2010
Date registered
11/11/2010

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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01239160