LymphedemaNCT02284373
Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
A study testing Flexitouch for 1 month in addition to routine wound care, Routine wound care for venous ulcers and lymphedema and Flexitouch pneumonic compression in people with Lymphedema, run by NYU Langone Health.
Trial summary
The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema. 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 for 1 month in addition to routine wound care, Routine wound care for venous ulcers and lymphedema and Flexitouch pneumonic compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Oct 2014
- 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
- Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days
- Presence of lymphedema in the lower extremity for at least 14 days
Who cannot join
- Pregnant women or women of childbearing potential not on contraception
- Previous use of the pneumatic compression device
- Class IV congestive heart failure
About this study
The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.
Read the detailed description
This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms:
Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
- Conditions
- Lymphedema
- Being tested
- Flexitouch for 1 month in addition to routine wound care, Routine wound care for venous ulcers and lymphedema, Flexitouch pneumonic compression
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch for 1 month in addition to routine wound careOther
simultaneous wound care and pneumonic compression
Routine wound care for venous ulcers and lymphedemaOther
wound care /dressings
Flexitouch pneumonic compressionDevice
pneumonic compression only
| Study group | Role | What they receive |
|---|---|---|
| Randomization Arm 1: | Other | 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded Receives: Other: Flexitouch for 1 month in addition to routine wound care |
| Randomization Arm 2: | Other | 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded. Receives: Other: Routine wound care for venous ulcers and lymphedema |
| Observational Arm 3 | Other | 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment. Receives: Device: Flexitouch pneumonic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionOct 2014
Why it stopped: Inadequate enrollment
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.
- More trials run by NYU Langone HealthThe 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
- Model description
- This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284373
- Sponsor's protocol ID
- 11-01568
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2014
- Last updated
- 13 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Pneumatic Compression Device for the Treatment of Venous Ulcers and Lymphedema
- ClinicalTrials.gov ID
- NCT02284373
- Acronym / sponsor ID
- 11-01568
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 13 Mar 2020
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 evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.
Detailed description
This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms:
Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms
| Arm | Type | Receives |
|---|---|---|
| Randomization Arm 1: | Other | Other: Flexitouch for 1 month in addition to routine wound care70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded |
| Randomization Arm 2: | Other | Other: Routine wound care for venous ulcers and lymphedema70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded. |
| Observational Arm 3 | Other | Device: Flexitouch pneumonic compression50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days
- Presence of lymphedema in the lower extremity for at least 14 days
Key exclusion criteria (3 listed)
- Pregnant women or women of childbearing potential not on contraception
- Previous use of the pneumatic compression device
- Class IV congestive heart failure
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 for 1 month in addition to routine wound caresimultaneous wound care and pneumonic compression | Other | Randomization Arm 1: |
| Routine wound care for venous ulcers and lymphedemawound care /dressings | Other | Randomization Arm 2: |
| Flexitouch pneumonic compressionpneumonic compression only | Device | Observational Arm 3 |
Primary outcome
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Time frame: 30 days
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch for 1 month in addition to routine wound care, Routine wound care for venous ulcers and lymphedema and Flexitouch pneumonic compression in people with Lymphedema, run by NYU Langone Health.
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 2 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: stopped early, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 13 Mar 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?
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire (time frame: 30 days). 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 13 Mar 2020.