LymphedemaELASTOLYMPHNCT05186142
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema
An observational study of Lymphedema and Lower Limb Lymphedema, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema Hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Lower Limb Lymphedema
- What is being tested?
- Ultrasonography / Ultrasound elastography
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 20 Oct 2019
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receinving intensive treatment for lower limb lymphedema at UHC Saint Eloi. Patients with lower limb lymphedema coming to UHC Saint Eloi for intensive treatment.
Who may be able to join
- Major patients with unilateral or bilateral lymphedema of the lower limb (s), stage II or III, of primary or secondary origin
- Major patients with admitted for the realization of an Intensive Decongestive Treatment (TDI) of three to five days in the lymphology unit of the Saint Eloi hospital, of Montpellier UHC.
Who cannot join
- Patients with different lymphedema localisation than the lower limbs
- Patient with amputated
- patient not consenting or included in another clinical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema
Hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression.
Read more
Patients who are undergoing intensive decongestive treatment for four or five days in the department perform an ultrasound check/examiantion on the first day.
During this echography, in 5 usual measurement points are made an ultrasound image recording (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an instantaneous measurement).
The study hypothesis is to note that intensive decongestive treatment has an impact on tissues flexibility and cutaneous and subcutaneous thickness.
No many authors discussed this suject, hence the interest of this study. All the data collected and the results obtained will serve for further studies.
- Conditions
- Lymphedema, Lower Limb Lymphedema
- Being tested
- Ultrasonography / Ultrasound elastography
- Keywords
- Skin suppleness, Elastography, lymphedema, Manual Lymphatic Drainage
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography / Ultrasound elastographyOther
Ultrasonography / Ultrasound elastography
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for treatment of lymphoedema | Patients hospitalized for treatment of lymphoedema Receives: Other: Ultrasonography / Ultrasound elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Elastography
number of Elastography
Measured: day 1 (pre treatment)
number of Elastography
number of Elastography
Measured: day 5 (post treatment)
Secondary outcomes (6)
number of Cutaneous thicknesses
number of Cutaneous thicknesses
Measured: day 1 (pre treatment)
number of Cutaneous thicknesses
number of Cutaneous thicknesses
Measured: day 5 (post treatment)
number of Subcutaneous thicknesses
number of Subcutaneous thicknesses
Measured: day 1 (pre treatment)
number of Subcutaneous thicknesses
number of Subcutaneous thicknesses
Measured: day 5 (post treatment)
number of Limb volumetry
number of Limb volumetry in milliliter
Measured: day 1 (pre treatment)
number of Limb volumetry
number of Limb volumetry in milliliter
Measured: day 5 (post treatment)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 May 2019
- Primary completion1 Aug 2019
- Study completion20 Oct 2019
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 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MESTRE GODIN Sandrine, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186142
- Sponsor's protocol ID
- RECHMPL19_0482
- Acronym
- ELASTOLYMPH
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2021
- Last updated
- 11 Jan 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.
- ClinicalTrials.gov ID
- NCT05186142
- Acronym / sponsor ID
- ELASTOLYMPH / RECHMPL19_0482
- Conditions
- Lymphedema, Lower Limb Lymphedema
- Keywords
- Skin suppleness, Elastography, lymphedema, Manual Lymphatic Drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 11 Jan 2022 (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.
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema
Hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression.
Patients who are undergoing intensive decongestive treatment for four or five days in the department perform an ultrasound check/examiantion on the first day.
During this echography, in 5 usual measurement points are made an ultrasound image recording (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an instantaneous measurement).
The study hypothesis is to note that intensive decongestive treatment has an impact on tissues flexibility and cutaneous and subcutaneous thickness.
No many authors discussed this suject, hence the interest of this study. All the data collected and the results obtained will serve for further studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for treatment of lymphoedema | – | Other: Ultrasonography / Ultrasound elastographyPatients hospitalized for treatment of lymphoedema |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receinving intensive treatment for lower limb lymphedema at UHC Saint Eloi. Patients with lower limb lymphedema coming to UHC Saint Eloi for intensive treatment.
Key inclusion criteria (2 listed)
- Major patients with unilateral or bilateral lymphedema of the lower limb (s), stage II or III, of primary or secondary origin
- Major patients with admitted for the realization of an Intensive Decongestive Treatment (TDI) of three to five days in the lymphology unit of the Saint Eloi hospital, of Montpellier UHC.
Key exclusion criteria (3 listed)
- Patients with different lymphedema localisation than the lower limbs
- Patient with amputated
- patient not consenting or included in another clinical research study.
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 |
|---|---|---|
| Ultrasonography / Ultrasound elastographyUltrasonography / Ultrasound elastography | Other | Patients hospitalized for treatment of lymphoedema |
Primary outcome
number of Elastography
Time frame: day 1 (pre treatment)
number of Elastography
number of Elastography
Time frame: day 5 (post treatment)
number of Elastography
6 secondary outcomes
number of Cutaneous thicknesses
Time frame: day 1 (pre treatment)
number of Cutaneous thicknesses
Time frame: day 5 (post treatment)
number of Subcutaneous thicknesses
Time frame: day 1 (pre treatment)
number of Subcutaneous thicknesses
Time frame: day 5 (post treatment)
number of Limb volumetry
Time frame: day 1 (pre treatment)
number of Limb volumetry
Time frame: day 5 (post treatment)]
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 11 Jan 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.
MESTRE GODIN Sandrine study director
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 Lymphedema and Lower Limb Lymphedema, 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 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: finished, as of the sponsor's last update on 11 Jan 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?
number of Elastography (time frame: day 1 (pre treatment)). 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?
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 11 Jan 2022.