Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05629026

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

Led by University Hospital, Toulouse · Updated on 2025-12-31

60

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lymphedema is a disorder of the lymphatic vascular system characterized by impaired lymphatic return and swelling of the extremities and accumulation of undrained interstitial fluid/lymph that results in fibrosis and adipose tissue deposition in the affected area. It can be an inherited condition (primary lymphedema) or occurs after cancer surgery and lymph node removal (secondary lymphedema). It causes a significant morbidity and is a common disabling disease affecting more than 200 million people worldwide, however there is no curative treatment for primary or secondary lymphedema.

CONDITIONS

Official Title

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary lymphedema or secondary lymphedema after breast cancer treatment
  • Male and female aged 18 to 75 years
  • Affiliated with a social security scheme in France
  • Signed informed consent before participation and procedures
  • No cancer recurrence for more than 3 years after surgery
  • Body Mass Index less than 35
  • Enrolled in a medical and educational care program for lymphedema
  • Wearing a compression orthosis on the affected limb
Not Eligible

You will not qualify if you...

  • Active or strongly suspected bacterial or fungal infection
  • Venous insufficiency in the limb with lymphedema
  • History of deep venous thrombosis in the affected limb
  • History of chronic inflammatory disease
  • Active cancer during study management
  • Participation in another therapeutic trial
  • Pregnant or breastfeeding women
  • Metastatic cancer
  • Bilateral breast cancer
  • Obliterative arterial disease
  • Multiple episodes of erysipelas
  • Active smoking status
  • Use of medications that delay healing (corticosteroids, immunosuppressants)
  • Use of blood-thinning medications (aspirin, antiplatelet agents, anticoagulants)
  • Allergy to Betadine
  • Under guardianship, trusteeship, or legal protection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Toulouse Hospital

Toulouse, France

Actively Recruiting

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Research Team

J

Julie MALLOIZEL-DELAUNAY, MD

CONTACT

C

Charline DAGUZAN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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