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New treatment option for Lymphedema
Official title Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
ClinicalTrials.gov ID: NCT05629026
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment.
- Male and female over the age of 18 and under 75.
- Patient affiliated to a social security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
- Patients with no recidive \> 3 years after cancer surgery.
You likely can't join if
- Patients with strong suspicion or with active bacterial or fungal infection.
- Patient with venous insufficiency associated with lymphedema.
- Patient with a history of deep venous thrombosis on the limb with lymphedema.
- History of chronic inflammatory disease.
- Active neoplasia during parallel management.
- Patient already included in another therapeutic trial.
See the full eligibility criteria
- Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment.
- Male and female over the age of 18 and under 75.
- Patient affiliated to a social security scheme in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
- Patients with no recidive \> 3 years after cancer surgery.
- Patients with Body Mass Index \<35.
- Patient enrolled in a care pathway for the management of their lymphedema (medical and educational care).
- Patients wearing a compression orthosis on the limb with lymphedema.
- Patients with strong suspicion or with active bacterial or fungal infection.
- Patient with venous insufficiency associated with lymphedema.
- Patient with a history of deep venous thrombosis on the limb with lymphedema.
- History of chronic inflammatory disease.
- Active neoplasia during parallel management.
- Patient already included in another therapeutic trial.
- Pregnant or breastfeeding woman.
- Metastatic cancer.
- Bilateral breast cancer.
- Obliterative arterial disease.
- Multiple erysipelas.
- Active smoking (delayed healing).
- Medicines that may promote delayed healing (Corticosteroid therapy, immunosuppressants).
- Medication that thins the blood (aspirin and antiplatelet agent, anti-coagulant).
- Betadine allergy.
- Patient under guardianship or trusteeship, persons placed under the protection of justice
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.