Lipedema, Lymphedema
Conditions
Keywords
Multimodal Ultrasonography, Strain Elastography, Differential Diagnosis, Power Doppler, ImageJ Analysis, Subcutaneous Tissue
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.
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_TESTMultimodal 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.
Sponsors
Kayseri City Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermal and Subcutaneous Tissue Thickness | Day 1 (At the time of ultrasound assessment) | Measurement of the dermal and subcutaneous tissue layers in millimeters (mm) using high-resolution B-mode ultrasonography to identify anatomical differences between the groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Stiffness Assessment via Strain Elastography | Day 1 (At the time of ultrasound assessment) | Evaluation of the biomechanical properties and relative stiffness of the subcutaneous tissue, assessed through color-coded elastogram scoring maps. |
| Quantitative Echogenicity Analysis | Day 1 (At the time of ultrasound assessment) | Pixel-based quantitative evaluation of tissue echogenicity from ultrasound images, analyzed using ImageJ software to establish objective imaging biomarkers. |
| Visual Analogue Scale (VAS) for Pain | Day 1 (Baseline clinical evaluation) | Assessment of the intensity of lower extremity pain reported by the participants on a scale from 0 (no pain) to 10 (worst imaginable pain). |
Countries
Turkey (Türkiye)
Contacts
CONTACTAbdullah Goktug Yazar
Outcome results
None listed