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LipedemaNCT07536646

Abdominal and Lower Extremity Adipose Tissue Elasticity in Patients With Lipedema

An observational study of Lipedema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lipedema is a chronic disorder characterized by abnormal bilateral fat deposition in the extremities, predominantly affecting women and typically beginning at puberty. The trunk, hands, and feet are usually spared. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Lipedema
What is being tested?
Shearwave elastography
How many people
95 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2026to 1 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Women aged ≥18 years with lipedema (stages 1-3) and healthy controls were included.

Who may be able to join

  • Women aged ≥18 years with lipedema (stages 1-3) and healthy controls with adequate cognitive function

Who cannot join

  • Age <18 years Lymphedema Edema of cardiac or nephrogenic origin Diabetes mellitus Thyroid dysfunction Oncological diseases Polyneuropathy or radiculopathy Advanced degenerative diseases affecting the extremities Use of antiepileptic or antidepressant drugs within the last 6 months Use of edema-inducing medications (e.g., corticosteroids, calcium channel blockers, gabapentin, pregabalin) Cognitive impairment preventing participation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Education and Training Hospital

    Istanbul, Ataşehir, 34752

Other trials in Turkey (Türkiye)

About this study

Official title: Abdominal and Lower Extremity Adipose Tissue Elasticity in Patients With Lipedema: A Shear Wave Elastography Study

Lipedema is a chronic disorder characterized by abnormal bilateral fat deposition in the extremities, predominantly affecting women and typically beginning at puberty. The trunk, hands, and feet are usually spared. Despite its relatively high prevalence, lipedema is frequently underrecognized in clinical practice and is often confused with conditions such as obesity, venous insufficiency, and lymphedema. Patients commonly present with pain, tenderness, and easy bruising.

Current imaging methods have demonstrated increased subcutaneous tissue thickness and fluid infiltration in lipedema; however, no imaging modality has yet been established as a definitive diagnostic tool. Shear wave elastography (SWE) is a noninvasive ultrasound-based technique that enables quantitative assessment of tissue stiffness and may provide additional information regarding tissue structure and mechanical properties.

In this study, we aim to compare lower extremity subcutaneous tissue stiffness in patients with lipedema and healthy controls using SWE. As a secondary objective, we aim to evaluate abdominal subcutaneous tissue stiffness in patients with lipedema and compare these findings with both lower extremity measurements in the same patients and abdominal measurements in individuals without lipedema.

Read the detailed description

Lipedema is a disorder characterized by abnormal bilateral fat deposition in the upper and lower extremities, typically beginning at puberty and predominantly affecting women. Its prevalence in the female population is estimated to be approximately 11%. The condition primarily involves the extremities, while the trunk, hands, and dorsum of the feet are typically spared. It has a genetic predisposition and is influenced by hormonal factors. Despite being relatively common, lipedema is frequently overlooked in daily clinical practice. Therefore, accurate clinical recognition of the disease is essential. In the differential diagnosis, it is often confused with obesity, venous insufficiency, and lymphedema. The main symptoms reported by patients with lipedema include pain, tenderness, and easy bruising.

Previous imaging studies using Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) have demonstrated thickening of the subcutaneous tissue without muscle edema, along with fluid infiltration within adipose tissue.

Ultrasonography (US) provides rapid and reliable diagnosis for many musculoskeletal lesions. Due to its ease of use, absence of radiation, and cost-effectiveness, it has become a preferred modality in musculoskeletal imaging. Elastography techniques vary depending on the method of compression, tissue displacement characteristics, and image acquisition techniques. The main types used in clinical practice include strain (compression) elastography, acoustic radiation force, shear wave elastography (SWE), and transient elastography. In addition to providing morphological information, SWE allows quantitative measurement of tissue elasticity and offers valuable insights into mechanical properties related to degeneration, injury, and healing.

This technology represents an ultrasound-based counterpart of manual palpation used by clinicians for tissue characterization. SWE is one of the ultrasound elastography techniques that utilizes shear wave speed (SWS) to assess tissue stiffness. During real-time B-mode ultrasonography, localized transient displacements in the tissue are generated by short-duration acoustic push pulses, producing shear waves. The propagation speed of these waves (SWS) is then recorded.

Measurements can be expressed in meters per second (m/s) or kilopascals (kPa), depending on the system. The square root of tissue elasticity is proportional to SWS, which directly correlates with tissue stiffness. This implies that stiffer tissues allow faster propagation of shear waves. Extracellular matrix components, particularly fibrotic deposits such as collagen, are the primary determinants of tissue stiffness. Ultrasound elastography has been established as an excellent diagnostic modality for conditions such as liver fibrosis, breast cancer, and thyroid cancer. In the field of musculoskeletal medicine, numerous studies have been conducted since the early 1990s, and its clinical application has increased in recent years .

In ultrasonographic studies of lipedema, no significant differences have been observed in the dermis, whereas increased thickness and decreased echogenicity of the subcutaneous tissue have been reported . However, there are currently no studies in the literature investigating lipedema using SWE. An imaging modality that definitively supports the clinical diagnosis of lipedema has not yet been established. The diagnostic performance of existing imaging methods remains limited. Prospective studies are needed to evaluate and compare the diagnostic performance of different imaging techniques. There is also a need for imaging modalities that focus on the pathophysiology of the disease .

In this study, we aimed to compare the stiffness of lower extremity subcutaneous tissue in patients with lipedema, characterized by diffuse subcutaneous tissue expansion, with that of a healthy population using SWE. As a secondary objective, we aimed to evaluate abdominal subcutaneous tissue stiffness using SWE in patients with lipedema and to compare it with both the lower extremity measurements in lipedema patients and the abdominal subcutaneous tissue stiffness in individuals without lipedema.

Conditions
Lipedema
Being tested
Shearwave elastography
Keywords
shearwave elastography, lipedema, tissue elasticity
Medical subject headings
Lipedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shearwave elastographyDiagnostic test

    Tissue elasticity was assessed using shear wave elastography (SWE) by a radiologist with 18 years of experience, using an RS 85 US device (Samsung Medison, Seoul, Korea) with an SL 10-2 linear probe. Patients were examined in the supine position, and a 10-mm layer of high-viscosity gel was applied to minimize compression. Bilateral measurements were obtained from four sites (anterior thigh, pretibial region, lateral leg, and abdomen), with three measurements per site averaged for analysis.

Study groups in NCT07536646
Study groupRoleWhat they receive
lipedema groupWomen aged ≥18 years with lipedema (stages 1-3)
Receives: Diagnostic Test: Shearwave elastography
control grouphealty controls
Receives: Diagnostic Test: Shearwave elastography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissue elasticity, as measured by shear-wave elastography (SWE)

    Comparison of tissue elasticity at the specified sites in both legs between patients with lipedema and healthy controls

    Measured: 1 day

Secondary outcomes (1)
  1. Tissue elasticity, as measured by shear-wave elastography (SWE)

    The elasticity of subcutaneous adipose tissue in the abdominal region and legs should be measured in patients with lipedema."

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536646
Sponsor's protocol ID
Shearwave study
Status last verified
Apr 2026
First submitted
11 Apr 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lipedema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tissue elasticity, as measured by shear-wave elastography (SWE) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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