LymphedemaACENCT01239160

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

A study testing Flexitouch System and Hydroven FPR in people with Lymphedema, run by Tactile Medical at 22 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphedema
What is being tested?: Flexitouch System and Hydroven FPR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 22 sitesin 3 countries
Study dates: 2 Nov 2010to 27 Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

22 sites in 3 countries.

Country

City, postcode or hospital

22 sites in 3 countries

United Kingdom11 sites

Royal Derby Hospital
Derby, DE22 3NE
University of Glasgow
Glasgow, Scotland, G12 8LL
St Oswalds Hospice
Gosforth, NE25 8SU
Kendal Lymphology Centre
Kendal, LA9 4BD
LOROS Hospice
Leicester, Leics, LE3 9QE
King's Mill Hospital
Mansfield, Nottinghamshire
Norfolk and Norwich University
Norwich
Queens Medical Center
Nottingham
Abertawe Bro Morgannwg University
Swansea, West Glamorgan
Lymphoedema Clinic, Singleton Hospital
Swansea, SA2 8QA
St Giles Hospice
Whittington, WS14 9LH

Other trials in United Kingdom

United States10 sites

Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
Fletcher Allen Health Care, Inc., University of Vermont
Colchester, Vermont, 05446
University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
Columbia, Missouri, 65203
Ohio State University Medical Center
Columbus, Ohio, 43210
Greenville Hospital Systems
Greenville, South Carolina, 29615
Hope Research Institute
Phoenix, Arizona, 85050
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Stony Brook University Medical Center
Stony Brook, New York, 11794-8191

Other trials in United States

Australia1 site

Flinders Medical Center
Adelaide

Other trials in Australia

About this study

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

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.

Read the 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.

Conditions: Lymphedema
Being tested: Flexitouch System, Hydroven FPR
Keywords: lymphedema, pneumatic compression device, randomised clinical trial, volume reduction
Medical subject headings: Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flexitouch SystemDevice
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
Hydroven FPRDevice
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.

Study groups in NCT01239160
Study group	Role	What they receive
Advanced PCD	Experimental	The use of an advanced PCD device to reduce and maintain limb volume Receives: Device: Flexitouch System
Simple PCD	Active comparator	The use of the Simple PCD is to reduce and maintain limb volume Receives: Device: Hydroven FPR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Secondary outcomes (1)

Adverse Events - Totals
Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial
Measured: Up to 24 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 201027 Jun 2012

First posted11 Nov 2010 (estimated)
Study start2 Nov 2010
Primary completion26 Oct 2011
Study completion27 Jun 2012

Why it stopped: Futility and underpowering of endpoint data

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphedemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01239160
Sponsor's protocol ID: Flexitouch 1010
Acronym: ACE
Status last verified: Oct 2020
First submitted: 10 Nov 2010
Last updated: 6 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
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A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
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Active, not recruiting
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All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)
ClinicalTrials.gov ID: NCT01239160
Acronym / sponsor ID: ACE / Flexitouch 1010
Conditions: Lymphedema
Keywords: lymphedema, pneumatic compression device, randomised clinical trial, volume reduction
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility and underpowering of endpoint data
Enrolment: 238 participants (actual)
Lead sponsor: Tactile MedicalIndustry (pharma, biotech, devices)
Study start: 2 Nov 2010 (actual)
Primary completion: 26 Oct 2011 (actual)
Study completion: 27 Jun 2012 (actual)
First posted: 11 Nov 2010 (estimated)
Results: Posted 14 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Secondary objectives of the study are Assessment of safety Quality of life Health economic parameters

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Advanced PCD	Experimental	Device: Flexitouch SystemThe use of an advanced PCD device to reduce and maintain limb volume
Simple PCD	Active comparator	Device: Hydroven FPRThe use of the Simple PCD is to reduce and maintain limb volume

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flexitouch SystemA 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	Device	Advanced PCD
Hydroven FPRThe 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.	Device	Simple PCD

Primary outcome

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

1 secondary outcome

Adverse Events - Totals
Time frame: Up to 24 weeks of treatment

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advanced PCD	114	89
Simple PCD	114	95
Treatment Not Assigned	10	0

Primary outcome: Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml

Time frame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.. Mean (Standard Deviation). Unit: ml

Measure	Advanced PCD n = 64	Simple PCD n = 66
Change Baseline to 1-Week	-11.1 (652.3)	75.3 (678.0)
Change Baseline to 4-Week	7.4 (636.3)	99.7 (691.3)
Change Baseline to 8-Week	77.7 (756.6)	167.9 (760.7)
Change Baseline to 12-Week	102.1 (724.5)	216.1 (919.3)

Population analysed: Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed a visit or who did not complete the assessment at the visit were excluded.

Primary outcome: Limb Volume Change Baseline to 12 Weeks of Treatment - Percent

Time frame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Advanced PCD n = 64	Simple PCD n = 66
Change Baseline to 1-Week	-0.4 (6.2)	0.9 (5.8)
Change Baseline to 4-Week	-0.1 (6.3)	0.9 (5.9)
Change Baseline to 8-Week	0.2 (7.4)	1.6 (6.8)
Change Baseline to 12-Week	0.6 (6.4)	2.2 (7.6)

Population analysed: Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed visits or who did not complete the assessment at the visit were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events reported below were collected from Baseline through 24 week visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced PCD	3 of 64 (4.7%)	25 of 64 (39.1%)	0 of 64
Simple PCD	3 of 66 (4.5%)	15 of 66 (22.7%)	0 of 66

Limitations and caveats (from the sponsor): Early termination DSMB recommendation on 23Jan2012 due to underpowered endpoint in 26Oct2011 dataset. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine J Moffatt, RN PhD study chair

Nottingham Trent University

Vaughan Keeley, MD study director

Derby Hospitals NHS Trust

Margaret Sneddon, RGN principal investigator

University of Glasgow

22 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flexitouch System and Hydroven FPR in people with Lymphedema, run by Tactile Medical at 22 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United Kingdom, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml (time frame: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.