Multimodal Ultrasound for Differentiating Lymphedema and Lipedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorKayseri City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Multimodal Ultrasound Assessment
Diagnostic testA 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Lymphedema Group1 intervention
Group B: Lipedema Group1 intervention
Group C: Healthy Control Group1 intervention
Trial outcomes
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.
Time frame
Day 1 (At the time of ultrasound assessment)Secondary outcomes
1
Tissue Stiffness Assessment via Strain Elastography
Evaluation of the biomechanical properties and relative stiffness of the subcutaneous tissue, assessed through color-coded elastogram scoring maps.
Time frame
Day 1 (At the time of ultrasound assessment)2
Quantitative Echogenicity Analysis
Pixel-based quantitative evaluation of tissue echogenicity from ultrasound images, analyzed using ImageJ software to establish objective imaging biomarkers.
Time frame
Day 1 (At the time of ultrasound assessment)3
Visual Analogue Scale (VAS) for Pain
Assessment of the intensity of lower extremity pain reported by the participants on a scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame
Day 1 (Baseline clinical evaluation)Sponsors and contacts
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Source ClinicalTrials.gov