Ultrasonographic Evaluation of Lymphedema and Lipedema: Differentiating with Quantitative Echogenicity and Elastography
This observational study aims to differentiate lymphedema and lipedema by evaluating the thickness of dermal and subcutaneous tissue layers using high-resolution B-mode ultrasonography.
Data Collection
Collected from today forward - ProspectiveConnective Tissue Diseases+3
+ Hemic and Lymphatic Diseases
+ Lymphatic Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: March 19, 2026
Actual date on which the first participant was enrolled.This study focuses on two conditions: lymphedema and lipedema, which often share similar symptoms, particularly in the lower limbs. The aim is to find a better and non-invasive way to differentiate between these two conditions for accurate treatment. Currently, methods like lymphoscintigraphy are used, but they are invasive and not always available. This study explores the use of high-resolution ultrasonography as a practical, non-invasive alternative. The study is important as it could lead to improved diagnosis and treatment for those with lymphedema and lipedema. The study will involve participants from three groups: those with lymphedema, those with lipedema, and a healthy control group. All participants will undergo a detailed ultrasound evaluation. This includes B-mode ultrasonography to measure the thickness of skin and underlying tissue, strain elastography to assess tissue stiffness, and power doppler to examine local blood flow. ImageJ software will be used to analyze the ultrasound images. By comparing these results across the three groups, the study aims to set standard ultrasound criteria for differentiating between lymphedema and lipedema.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location