Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

NCT07489248 | Recruiting

• 1 other identifier: 2025-564
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Lipedema

Keywords

Multimodal Ultrasonography; Strain Elastography; Differential Diagnosis; Power Doppler; ImageJ Analysis; Subcutaneous Tissue

Outcome Measures

Primary Outcomes (1)

• Dermal and Subcutaneous Tissue Thickness

  Measurement of the dermal and subcutaneous tissue layers in millimeters (mm) using high-resolution B-mode ultrasonography to identify anatomical differences between the groups.

  Day 1 (At the time of ultrasound assessment)

Secondary Outcomes (3)

• Tissue Stiffness Assessment via Strain Elastography

  Day 1 (At the time of ultrasound assessment)

• Quantitative Echogenicity Analysis

  Day 1 (At the time of ultrasound assessment)

• Visual Analogue Scale (VAS) for Pain

  Day 1 (Baseline clinical evaluation)

Study Arms (3)

Lymphedema Group

Patients clinically diagnosed with lower extremity lymphedema. Participants in this group will undergo a non-invasive multimodal ultrasound assessment (including B-mode, strain elastography, power Doppler, and ImageJ analysis) to evaluate tissue characteristics.

Diagnostic Test: Multimodal Ultrasound Assessment

Lipedema Group

Patients clinically diagnosed with lipedema of the lower extremities. Participants in this group will undergo the identical non-invasive multimodal ultrasound assessment protocol to evaluate tissue echogenicity, thickness, and stiffness.

Diagnostic Test: Multimodal Ultrasound Assessment

Healthy Control Group

Healthy volunteers with no history or clinical signs of chronic lower extremity edema, lymphedema, or lipedema. This group will undergo the same multimodal ultrasound assessment to establish baseline normative values for comparison.

Diagnostic Test: Multimodal Ultrasound Assessment

Interventions

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.

Also known as: B-mode Ultrasonography, Strain Elastography, Power Doppler, ImageJ Analysis

Healthy Control Group; Lipedema Group; Lymphedema Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients presenting to the Physical Medicine and Rehabilitation outpatient clinic with complaints of lower extremity swelling, diagnosed clinically with either lymphedema or lipedema. A healthy control group, matched for general demographic characteristics, will be recruited from volunteers without any lower extremity pathologies.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• Rockson SG. Lymphedema. Am J Med. 2001 Mar;110(4):288-95. doi: 10.1016/s0002-9343(00)00727-0.

  PMID: 11239847 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Lipedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Abdullah Goktug Yazar

CONTACT

+905309731140; abdullahgoktug.yazar@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uz. Dr.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)