Clinical trial NCT05186142: Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema
Official title: Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lower Limb Lymphedema
Keywords: Skin suppleness
Elastography
lymphedema
Manual Lymphatic Drainage
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* Patients with different lymphedema localisation than the lower limbs
* Patient with amputated
* patient not consenting or included in another clinical research study.

Primary outcomes:
measure: number of Elastography
timeFrame: day 1 (pre treatment)
measure: number of Elastography
timeFrame: day 5 (post treatment)
Secondary outcomes:
measure: number of Cutaneous thicknesses
timeFrame: day 1 (pre treatment)
measure: number of Cutaneous thicknesses
timeFrame: day 5 (post treatment)
measure: number of Subcutaneous thicknesses
timeFrame: day 1 (pre treatment)
measure: number of Subcutaneous thicknesses
timeFrame: day 5 (post treatment)
measure: number of Limb volumetry
timeFrame: day 1 (pre treatment)
measure: number of Limb volumetry
timeFrame: day 5 (post treatment)]
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: MESTRE GODIN Sandrine
role: STUDY_DIRECTOR
References: