NCT07489248 Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

Trial Parameters

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Brief Summary

The aim of this observational study is to evaluate the diagnostic value of multimodal ultrasonography in differentiating between lymphedema and lipedema. Differentiating these two chronic conditions based solely on clinical examination can be challenging due to overlapping symptoms. This study will utilize various non-invasive ultrasound techniques-including B-mode ultrasound, strain elastography, power Doppler, and quantitative ImageJ analysis-to compare tissue characteristics among patients with lymphedema, patients with lipedema, and healthy controls. The goal is to identify reliable, non-invasive imaging biomarkers that can facilitate early and accurate diagnosis, thereby optimizing patient management.

Eligibility Criteria

Inclusion Criteria: Individuals aged 18 to 75 years. Clinical diagnosis of lower extremity lymphedema (for the lymphedema group). Clinical diagnosis of lower extremity lipedema (for the lipedema group). Healthy individuals with no history or clinical signs of chronic lower extremity edema (for the control group). Exclusion Criteria: Presence of active local infections, such as cellulitis or erysipelas, in the lower extremities. History of deep vein thrombosis (DVT) or severe chronic venous insufficiency. Systemic conditions that can cause secondary edema, including congestive heart failure, chronic kidney disease, or severe hepatic impairment. Previous surgical interventions on the affected lower extremities, including liposuction, lymphatic reconstructive surgery, or major orthopedic surgeries. Active malignancy or currently undergoing radiotherapy/chemotherapy. Pregnancy or lactation.

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