NCT05629026 Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
| NCT ID | NCT05629026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-21 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment. 2. Male and female over the age of 18 and under 75. 3. Patient affiliated to a social security scheme in France. 4. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study. 5. Patients with no recidive \> 3 years after cancer surgery. 6. Patients with Body Mass Index \<35. 7. Patient enrolled in a care pathway for the management of their lymphedema (medical and educational care). 8. Patients wearing a compression orthosis on the limb with lymphedema. Exclusion Criteria: 1. Patients with strong suspicion or with active bacterial or fungal infection. 2. Patient with venous insufficiency associated with lymphedema. 3. Patient with a history of deep venous thrombosis on the limb with lymphedema. 4. History of chronic inflammatory disease. 5. Active neoplasia during parallel management. 6. Patient already included in another therapeutic trial. 7. Pregnant or breastfeeding woman. 8. Metastatic cancer. 9. Bilateral breast cancer. 10. Obliterative arterial disease. 11. Multiple erysipelas. 12. Active smoking (delayed healing). 13. Medicines that may promote delayed healing (Corticosteroid therapy, immunosuppressants). 14. Medication that thins the blood (aspirin and antiplatelet agent, anti-coagulant). 15. Betadine allergy. 16. Patient under guardianship or trusteeship, persons placed under the protection of justice
Contact & Investigator
Julie Malloizel-Delaunay, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT05629026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05629026 currently recruiting?
Yes, NCT05629026 is actively recruiting participants. Contact the research team at malloizel-delaunay.j@chu-toulouse.fr for enrollment information.
Where is the NCT05629026 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT05629026 clinical trial?
NCT05629026 is sponsored by University Hospital, Toulouse. The principal investigator is Julie Malloizel-Delaunay, MD at University Hospital, Toulouse. The trial plans to enroll 60 participants.