LymphoedemaNCT05169086
Comparison of Two Types of Bandages in the Treatment of Lymphoedema
An observational study of Lymphoedema, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10). Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoedema
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 20 Jan 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population corresponds to patients with primary or secondary lymphedema receiving intensive decongestant treatment at the Montpellier University Hospital. Patients must be of legal age and have unilateral stage 2 or 3 lymphedema.
Who may be able to join
- Adult with unilateral lower limb lymphoedema
- Stage 2 or 3 lymphoedema
- 1st intensive decongestant treatment
- Ability to sit on a cycloergometer
Who cannot join
- Severe cardiac disease
- Infectious dermoepidermitis
- Bandage unbearable for the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study
The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).
Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.
The evaluation is based on the volumetric difference, skin quality and quality of life of these patients
- Conditions
- Lymphoedema
- Keywords
- Lymphology, Chronic disease, reduction bandages
- Medical subject headings
- Lymphedema, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimetry of the affected limb
The physiotherapist measures the perimeter of the limb with a tape measure
Measured: day 1
Perimetry of the affected limb
The physiotherapist measures the perimeter of the limb with a tape measure
Measured: Day 2
Volumetry of the affected limb
the volume is calculated using computer software.
Measured: day 1
Volumetry of the affected limb
the volume is calculated using computer software.
Measured: Day 2
Secondary outcomes (2)
Quality of life questionnaire
The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later
Measured: day 1
Quality of life questionnaire
The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later
Measured: one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Jan 2022
- Study completion20 Jan 2022
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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- nicolas Erdocio, student, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169086
- Sponsor's protocol ID
- RECHMPL21_0620
- Status last verified
- Apr 2022
- First submitted
- 17 Nov 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT05169086
- Acronym / sponsor ID
- RECHMPL21_0620
- Conditions
- Lymphoedema
- Keywords
- Lymphology, Chronic disease, reduction bandages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- 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 study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).
Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.
The evaluation is based on the volumetric difference, skin quality and quality of life of these patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to patients with primary or secondary lymphedema receiving intensive decongestant treatment at the Montpellier University Hospital. Patients must be of legal age and have unilateral stage 2 or 3 lymphedema.
Key inclusion criteria (4 listed)
- Adult with unilateral lower limb lymphoedema
- Stage 2 or 3 lymphoedema
- 1st intensive decongestant treatment
- Ability to sit on a cycloergometer
Key exclusion criteria (3 listed)
- Severe cardiac disease
- Infectious dermoepidermitis
- Bandage unbearable for the patient
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
Perimetry of the affected limb
Time frame: day 1
The physiotherapist measures the perimeter of the limb with a tape measure
Perimetry of the affected limb
Time frame: Day 2
The physiotherapist measures the perimeter of the limb with a tape measure
Volumetry of the affected limb
Time frame: day 1
the volume is calculated using computer software.
Volumetry of the affected limb
Time frame: Day 2
the volume is calculated using computer software.
2 secondary outcomes
Quality of life questionnaire
Time frame: day 1
Quality of life questionnaire
Time frame: one month later
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 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
nicolas Erdocio, student principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoedema, run by University Hospital, Montpellier at 1 site in France.
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 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: finished, as of the sponsor's last update on 12 Apr 2022. 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 France. 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 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?
Perimetry of the affected limb (time frame: day 1). The study lists 4 primary outcomes in all. 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 12 Apr 2022.