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

Lymphedema Clinical Trial

— ELASTOLYMPH  

Official title:

Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186142
• Other study ID #: RECHMPL19_0482
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: October 20, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 20, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• Ultrasonography / Ultrasound elastography
Ultrasonography / Ultrasound elastography

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of Elastography	number of Elastography	day 1 (pre treatment)
Primary	number of Elastography	number of Elastography	day 5 (post treatment)
Secondary	number of Cutaneous thicknesses	number of Cutaneous thicknesses	day 1 (pre treatment)
Secondary	number of Cutaneous thicknesses	number of Cutaneous thicknesses	day 5 (post treatment)
Secondary	number of Subcutaneous thicknesses	number of Subcutaneous thicknesses	day 1 (pre treatment)
Secondary	number of Subcutaneous thicknesses	number of Subcutaneous thicknesses	day 5 (post treatment)
Secondary	number of Limb volumetry	number of Limb volumetry in milliliter	day 1 (pre treatment)
Secondary	number of Limb volumetry	number of Limb volumetry in milliliter	day 5 (post treatment)]