Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

Sponsor
Kayseri City Hospital
Study ID
NCT07489248
Status
Recruiting
Apply to this trial

Conditions

  • Lipedema
  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Mar 19, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Dermal and Subcutaneous Tissue Thickness [ Time Frame: Day 1 (At the time of ultrasound assessment) ]

Central Contacts

Related Studies