Using multimodal ultrasound to tell lymphedema apart from lipedema
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
This study will test whether combining B-mode ultrasound, strain elastography, power Doppler, and ImageJ analysis can accurately tell adults with lower-extremity lymphedema from those with lipedema and from healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Kayseri City Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kayseri, Kocasinan) |
| Trial ID | NCT07489248 on ClinicalTrials.gov |
What this trial studies
This cross-sectional observational project will enroll adults into three groups — lymphedema, lipedema, and healthy controls — and perform standardized multimodal ultrasound exams on the lower limbs. Imaging includes B-mode measurements of dermal and subcutaneous thickness, strain elastography for tissue stiffness, power Doppler for microvascularity, and quantitative pixel-based ImageJ echogenicity analysis. Collected parameters will be compared across groups to identify reproducible imaging biomarkers and determine which single modalities or combinations provide the best diagnostic separation. The goal is to develop non-invasive, reproducible imaging criteria that could reduce reliance on invasive tests and improve diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with a clinical diagnosis of lower-extremity lymphedema or lipedema, or healthy adults without chronic leg swelling who can attend imaging visits.
Not a fit: Patients with active lower-limb infection, prior major lower-limb surgery (including liposuction or lymphatic reconstruction), systemic causes of edema (heart, kidney, or liver failure), recent DVT, active malignancy under treatment, or who are pregnant or lactating are excluded and unlikely to benefit from the imaging comparisons.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and more accurate way to diagnose lymphedema versus lipedema, enabling earlier and better-targeted treatment.
How similar studies have performed: Prior smaller studies using ultrasound elastography and echogenicity have shown promising differences between these conditions, but a standardized multimodal protocol for reliable differentiation is not yet fully validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kayseri, Kocasinan
- Kayseri City Hospital — Kayseri, Kocasinan, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Abdullah Goktug Yazar
- Email: abdullahgoktug.yazar@sbu.edu.tr
- Phone: +905309731140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.