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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT05186142
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema; Lower Limb Lymphedema	Other: Ultrasonography / Ultrasound elastography

Study Design

• Study Type: Observational
• Actual Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Oct 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of Elastography [day 1 (pre treatment)]

   number of Elastography

2. number of Elastography [day 5 (post treatment)]

   number of Elastography

Secondary Outcome Measures

1. number of Cutaneous thicknesses [day 1 (pre treatment)]

   number of Cutaneous thicknesses

2. number of Cutaneous thicknesses [day 5 (post treatment)]

   number of Cutaneous thicknesses

3. number of Subcutaneous thicknesses [day 1 (pre treatment)]

   number of Subcutaneous thicknesses

4. number of Subcutaneous thicknesses [day 5 (post treatment)]

   number of Subcutaneous thicknesses

5. number of Limb volumetry [day 1 (pre treatment)]

   number of Limb volumetry in milliliter

6. number of Limb volumetry [day 5 (post treatment)]]

   number of Limb volumetry in milliliter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT05186142
• Other Study ID Numbers: RECHMPL19_0482
• First Posted: Jan 11, 2022
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Skin suppleness; Elastography; lymphedema; Manual Lymphatic Drainage
• Additional relevant MeSH terms: Lymphedema

Study Results

No Results Posted as of Jan 11, 2022