LymphoedemaPOLITNCT01864044
Prospective Observational Lymphoedema Intensive Treatment
An observational study of Lymphoedema, run by Thuasne.
Trial summary
The aim of this observational study was to describe usual practices in lymphedema management in France. It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoedema
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2012
- Phase
- Observational
- 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
Study population: All consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology and an indication for intensive decongestive therapy (IDT) were enrolled.
Who may be able to join
- consecutive adult patients
- hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
- indication for intensive decongestive therapy (IDT)
Who cannot join
- bilateral lymphedema,
- lymphedema of both upper and lower limbs,
- intensive decongestive therapy in the previous 6 months,
- cancer recurrence,
- systolic pressure index < 0.5
About this study
The aim of this observational study was to describe usual practices in lymphedema management in France.
It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.
Read the detailed description
Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.
These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.
- Conditions
- Lymphoedema
- Medical subject headings
- Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in affected limb volume
According to the site, the first phase can lasts 1, 2 or 3 weeks.
Measured: At the end of 1st phase of Complex Decongestive Therapy and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphoedemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864044
- Sponsor's protocol ID
- EC07
- Acronym
- POLIT
- Status last verified
- Nov 2023
- First submitted
- 13 May 2013
- Last updated
- 22 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Lymphoedema Intensive Treatment
- ClinicalTrials.gov ID
- NCT01864044
- Acronym / sponsor ID
- POLIT / EC07
- Conditions
- Lymphoedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 May 2013 (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 aim of this observational study was to describe usual practices in lymphedema management in France.
It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.
Detailed description
Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.
These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology and an indication for intensive decongestive therapy (IDT) were enrolled.
Key inclusion criteria (3 listed)
- consecutive adult patients
- hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
- indication for intensive decongestive therapy (IDT)
Key exclusion criteria (5 listed)
- bilateral lymphedema,
- lymphedema of both upper and lower limbs,
- intensive decongestive therapy in the previous 6 months,
- cancer recurrence,
- systolic pressure index < 0.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in affected limb volume
Time frame: At the end of 1st phase of Complex Decongestive Therapy and 6 months later
According to the site, the first phase can lasts 1, 2 or 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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?
An observational study of Lymphoedema, run by Thuasne.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in affected limb volume (time frame: At the end of 1st phase of Complex Decongestive Therapy and 6 months later). 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 22 Nov 2023.