Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

Официальное название

ULTRASONOGRAPHIC EVALUATION OF LOWER EXTREMITY SKIN AND SUBCUTANEOUS TISSUE WITH QUANTITATIVE ECHOGENICITY AND ELASTOGRAPHY IN LYMPHEDEMA, LIPEDEMA, AND HEALTHY CONTROL GROUPS: A CONTROLLED CLINICAL STUDY

Обзор

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.

Подробное описание

Lymphedema and lipedema are distinct pathological entities that often present with similar clinical features, particularly in the lower extremities. Accurate differential diagnosis is crucial for appropriate therapeutic intervention. While modalities like lymphoscintigraphy serve as standard diagnostic tools for lymphedema, they are invasive and not universally accessible. High-resolution ultrasonography provides a practical, non-invasive alternative for tissue assessment.

This cross-sectional, observational study will recruit participants and categorize them into three groups: a lymphedema group, a lipedema group, and a healthy control group. Comprehensive multimodal ultrasound evaluations will be performed on all participants. The assessment protocol includes:

B-mode Ultrasonography: To measure the thickness of the dermis and subcutaneous tissue layers.

Strain Elastography: To evaluate the biomechanical properties and relative stiffness of the affected tissues.

Power Doppler: To assess the local microvascularity and blood flow patterns.

ImageJ Software Analysis: To perform quantitative pixel-based echogenicity evaluation of the ultrasound images.

By systematically comparing these ultrasonographic parameters across the three groups, this study aims to establish standard, reproducible imaging criteria. The primary objective is to determine which specific ultrasound modalities, or combinations thereof, offer the highest diagnostic accuracy in differentiating lymphedema from lipedema in clinical practice.

Вмешательства

• Диагностический тест Multimodal Ultrasound Assessment
  A comprehensive, non-invasive ultrasonographic evaluation of the lower extremities. The protocol includes B-mode ultrasound for measuring dermis and subcutaneous tissue thickness, strain elastography for assessing tissue biomechanical stiffness, and Power Doppler for evaluating local microvascularity. Additionally, quantitative echogenicity of the tissues will be analyzed using ImageJ software.

Первичные конечные точки

• Dermal and Subcutaneous Tissue Thickness [Срок оценки: Day 1 (At the time of ultrasound assessment)]

Вторичные конечные точки (3)

• Tissue Stiffness Assessment via Strain Elastography [Срок оценки: Day 1 (At the time of ultrasound assessment)]
• Quantitative Echogenicity Analysis [Срок оценки: Day 1 (At the time of ultrasound assessment)]
• Visual Analogue Scale (VAS) for Pain [Срок оценки: Day 1 (Baseline clinical evaluation)]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Kayseri City Hospital — Kayseri

Публикации

• Gerard N, Farmakis IT, Valerio L, Hobohm L, Keller K, Kucher N, Barco S, Grigorean A. Epidemiological Study of Lymphedema Prevalence and Comorbidities in Hospitalized Patients in the United States. J Clin Med. 2025 Nov 17;14(22):8156. doi: 10.3390/jcm14228156. PMID 41303192
• Mortimer PS, Rockson SG. New developments in clinical aspects of lymphatic disease. J Clin Invest. 2014 Mar;124(3):915-21. doi: 10.1172/JCI71608. Epub 2014 Mar 3. PMID 24590276
• Rockson SG. Lymphedema. Am J Med. 2001 Mar;110(4):288-95. doi: 10.1016/s0002-9343(00)00727-0. PMID 11239847

Идентификаторы

NCT: NCT07489248 · 2025-564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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