Multimodal Ultrasound for Differentiating Lymphedema and Lipedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal Ultrasound Assessment.
- Who it may be relevant to
- Registry conditions: Lymphedema, Lipedema. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Dermal and Subcutaneous Tissue Thickness [Time frame: Day 1 (At the time of ultrasound assessment)]
Secondary outcome measures (3)
- Tissue Stiffness Assessment via Strain Elastography [Time frame: Day 1 (At the time of ultrasound assessment)]
- Quantitative Echogenicity Analysis [Time frame: Day 1 (At the time of ultrasound assessment)]
- Visual Analogue Scale (VAS) for Pain [Time frame: Day 1 (Baseline clinical evaluation)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Kayseri City Hospital — Kayseri
Publications
- 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
Identifiers
NCT: NCT07489248 · 2025-564