NCT07489248

Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Kayseri City Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Lymphedema
• Lipedema

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2026-03-19
• Primary completion: 2026-08-01
• Completion: 2026-09-15
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)