Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema (ELASTOLYMPH)

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.

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 Overview

• Status: Completed
• Conditions: Lymphedema; Lower Limb Lymphedema
• Intervention / Treatment: Other: Ultrasonography / Ultrasound elastography

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients hospitalized for treatment of lymphoedema	Other: Ultrasonography / Ultrasound elastography; Ultrasonography / Ultrasound elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Elastography	number of Elastography	day 1 (pre treatment)
number of Elastography	number of Elastography	day 5 (post treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Cutaneous thicknesses	number of Cutaneous thicknesses	day 1 (pre treatment)
number of Cutaneous thicknesses	number of Cutaneous thicknesses	day 5 (post treatment)
number of Subcutaneous thicknesses	number of Subcutaneous thicknesses	day 1 (pre treatment)
number of Subcutaneous thicknesses	number of Subcutaneous thicknesses	day 5 (post treatment)
number of Limb volumetry	number of Limb volumetry in milliliter	day 1 (pre treatment)
number of Limb volumetry	number of Limb volumetry in milliliter	day 5 (post treatment)]

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: MESTRE GODIN Sandrine, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Elastography; lymphedema; Manual Lymphatic Drainage; Skin suppleness
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: RECHMPL19_0482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No