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

NCT05186142 | Completed

• 1 other identifier: RECHMPL19_0482
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Lower Limb Lymphedema

Keywords

Skin suppleness; Elastography; lymphedema; Manual Lymphatic Drainage

Outcome Measures

Primary Outcomes (2)

• number of Elastography

  number of Elastography

  day 1 (pre treatment)

• number of Elastography

  number of Elastography

  day 5 (post treatment)

Secondary Outcomes (6)

• number of Cutaneous thicknesses

  day 1 (pre treatment)

• number of Cutaneous thicknesses

  day 5 (post treatment)

• number of Subcutaneous thicknesses

  day 1 (pre treatment)

• number of Subcutaneous thicknesses

  day 5 (post treatment)

• number of Limb volumetry

  day 1 (pre treatment)

Study Arms (1)

Patients hospitalized for treatment of lymphoedema

Patients hospitalized for treatment of lymphoedema

Other: Ultrasonography / Ultrasound elastography

Interventions

Ultrasonography / Ultrasound elastography OTHER

Ultrasonography / Ultrasound elastography

Patients hospitalized for treatment of lymphoedema

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Lymphedema

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• MESTRE GODIN Sandrine

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: January 11, 2022
• Study Start: May 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: October 20, 2019
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

FR (1)