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Completed

NCT Number: NCT05186142

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

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lower Limb Lymphedema Lymphatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonography / Ultrasound elastography

Other

Ultrasonography / Ultrasound elastography

Primary outcomes

  1. number of Elastography

    Time frame: day 1 (pre treatment)

    number of Elastography

  2. number of Elastography

    Time frame: day 5 (post treatment)

    number of Elastography

Secondary outcomes

  1. number of Cutaneous thicknesses

    Time frame: day 1 (pre treatment)

    number of Cutaneous thicknesses

  2. number of Cutaneous thicknesses

    Time frame: day 5 (post treatment)

    number of Cutaneous thicknesses

  3. number of Subcutaneous thicknesses

    Time frame: day 1 (pre treatment)

    number of Subcutaneous thicknesses

  4. number of Subcutaneous thicknesses

    Time frame: day 5 (post treatment)

    number of Subcutaneous thicknesses

  5. number of Limb volumetry

    Time frame: day 1 (pre treatment)

    number of Limb volumetry in milliliter

  6. number of Limb volumetry

    Time frame: day 5 (post treatment)]

    number of Limb volumetry in milliliter

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ELASTOLYMPH

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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