Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07489248

Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Kayseri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location status: Recruiting

Location contact

Abdullah Goktug Yazar, MD

CONTACT

[email protected]

+905309731140

Ayse Guc, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Ultrasound Assessment

Diagnostic Test

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.

Other names: B-mode Ultrasonography, Strain Elastography, Power Doppler, ImageJ Analysis

Primary outcomes

  1. Dermal and Subcutaneous Tissue Thickness

    Time frame: 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 outcomes

  1. Tissue Stiffness Assessment via Strain Elastography

    Time frame: 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.

  2. Quantitative Echogenicity Analysis

    Time frame: 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.

  3. Visual Analogue Scale (VAS) for Pain

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Goktug Yazar

CONTACT

[email protected]

+905309731140

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.