LymphedemaPCD-LYMPHNCT00951067
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
A study testing Exercise, Elevation, and Compression Garment, E0650 PCD with non-sequential waveform and E0651 PCD with sequential, non-gradient waveform in people with Lymphedema, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine how well different treatments for acquired lymphedema work. The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Exercise, Elevation, and Compression Garment, E0650 PCD with non-sequential waveform and E0651 PCD with sequential, non-gradient waveform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients diagnosed with acquired lymphedema of the arm.
Who cannot join
- Refusal of consent
- Unlikely compliance with the research protocol
- Acute upper extremity DVT
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston at Waltham
Waltham, Massachusetts, 02453
About this study
Official title: Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
The purpose of this study is to determine how well different treatments for acquired lymphedema work.
The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
Read the detailed description
This study will compare 5 non-invasive lymphedema treatments.
Patients will be assigned to either:
- A combination of arm exercises, arm elevation, and wearing of a compression garment every day
OR
- One of four possible pneumatic compression devices for just two hours every day.
Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.
None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.
The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.
- Conditions
- Lymphedema
- Being tested
- Exercise, Elevation, and Compression Garment, E0650 PCD with non-sequential waveform, E0651 PCD with sequential, non-gradient waveform, E0652 PCD with sequential, gradient waveform, E0652 PCD with peristaltic pulse waveform
- Keywords
- Lymphedema, Breast Cancer, Upper Extremity, Arm
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, Elevation, and Compression GarmentOther
Patients will be asked to daily:
- exercise
- elevate arm
- wear an arm compression garment
E0650 PCD with non-sequential waveformDevice
Also called Brand: Huntleigh Flowtron Hydroven™ 3
Use of an E0650 PCD with non-sequential waveform for two hours every day.
E0651 PCD with sequential, non-gradient waveformDevice
Also called Brand: Petite Basic System (Model 701A) Lympha Press
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
E0652 PCD with sequential, gradient waveformDevice
Also called Brand: Bio Compression Sequential Circulator 3008
Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
E0652 PCD with peristaltic pulse waveformDevice
Also called NormaTec brand
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Exercise, Elevation, and Garment Compression Receives: Other: Exercise, Elevation, and Compression Garment |
| Group B | Active comparator | Pneumatic Compression Device (B) Receives: Device: E0650 PCD with non-sequential waveform |
| Group C | Active comparator | Pneumatic Compression Device (C) Receives: Device: E0651 PCD with sequential, non-gradient waveform |
| Group D | Active comparator | Pneumatic Compression Device (D) Receives: Device: E0652 PCD with sequential, gradient waveform |
| Group E | Active comparator | Pneumatic Compression Device (E) Receives: Device: E0652 PCD with peristaltic pulse waveform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Volume
Measured: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Secondary outcomes (2)
Infection (cellulitis)
Measured: Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Quality of Life Survey
Measured: Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Funding not available to continue with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NormaTec Industries LP
- Responsible party
- Sponsor
- Investigators
- Arin K Greene, MD, MMSc, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951067
- Sponsor's protocol ID
- AQ-UE-LYMPHEDMA-PCD-RCT
- Acronym
- PCD-LYMPH
- Status last verified
- Jan 2014
- First submitted
- 3 Aug 2009
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
- ClinicalTrials.gov ID
- NCT00951067
- Acronym / sponsor ID
- PCD-LYMPH / AQ-UE-LYMPHEDMA-PCD-RCT
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Breast Cancer, Upper Extremity, Arm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not available to continue with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- NormaTec Industries LP
- Study start
- Aug 2009
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how well different treatments for acquired lymphedema work.
The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
Detailed description
This study will compare 5 non-invasive lymphedema treatments.
Patients will be assigned to either:
- A combination of arm exercises, arm elevation, and wearing of a compression garment every day
OR
- One of four possible pneumatic compression devices for just two hours every day.
Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.
None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.
The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Exercise, Elevation, and Compression GarmentExercise, Elevation, and Garment Compression |
| Group B | Active comparator | Device: E0650 PCD with non-sequential waveformPneumatic Compression Device (B) |
| Group C | Active comparator | Device: E0651 PCD with sequential, non-gradient waveformPneumatic Compression Device (C) |
| Group D | Active comparator | Device: E0652 PCD with sequential, gradient waveformPneumatic Compression Device (D) |
| Group E | Active comparator | Device: E0652 PCD with peristaltic pulse waveformPneumatic Compression Device (E) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with acquired lymphedema of the arm.
Key exclusion criteria (3 listed)
- Refusal of consent
- Unlikely compliance with the research protocol
- Acute upper extremity DVT
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 |
|---|---|---|
| Exercise, Elevation, and Compression GarmentPatients will be asked to daily: * exercise * elevate arm * wear an arm compression garment | Other | Group A |
| E0650 PCD with non-sequential waveformAlso: Brand: Huntleigh Flowtron Hydroven™ 3Use of an E0650 PCD with non-sequential waveform for two hours every day. | Device | Group B |
| E0651 PCD with sequential, non-gradient waveformAlso: Brand: Petite Basic System (Model 701A) Lympha PressUse of an E0651 PCD with sequential, non-gradient waveform for two hours every day | Device | Group C |
| E0652 PCD with sequential, gradient waveformAlso: Brand: Bio Compression Sequential Circulator 3008Use of an E0652 PCD with sequential, gradient waveform for two hours every day. | Device | Group D |
| E0652 PCD with peristaltic pulse waveformAlso: NormaTec brandUse the E0652 PCD with peristaltic pulse waveform for two hours every day. | Device | Group E |
Primary outcome
Arm Volume
Time frame: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
2 secondary outcomes
Infection (cellulitis)
Time frame: Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Quality of Life Survey
Time frame: Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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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.
Arin K Greene, MD, MMSc principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Elevation, and Compression Garment, E0650 PCD with non-sequential waveform and E0651 PCD with sequential, non-gradient waveform in people with Lymphedema, run by Boston Children's Hospital at 1 site in United States.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Arm Volume (time frame: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2014.