LymphedemaNCT07489248
Multimodal Ultrasound for Differentiating Lymphedema and Lipedema
An observational study of Lymphedema and Lipedema, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Lipedema
- What is being tested?
- Multimodal Ultrasound Assessment
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 28 Feb 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Individuals aged 18 to 65 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kayseri, Kocasinan, 38080
About this study
Official title: 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
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.
Read the detailed description
Lymphedema and lipedema are distinct pathological entities that often present with similar clinical features, particularly in the lower extremities. Accurate differential diagnosis is crucial for appropriate therapeutic intervention. While modalities like lymphoscintigraphy serve as standard diagnostic tools for lymphedema, they are invasive and not universally accessible. High-resolution ultrasonography provides a practical, non-invasive alternative for tissue assessment.
This cross-sectional, observational study will recruit participants and categorize them into three groups: a lymphedema group, a lipedema group, and a healthy control group. Comprehensive multimodal ultrasound evaluations will be performed on all participants. The assessment protocol includes:
B-mode Ultrasonography: To measure the thickness of the dermis and subcutaneous tissue layers.
Strain Elastography: To evaluate the biomechanical properties and relative stiffness of the affected tissues.
Power Doppler: To assess the local microvascularity and blood flow patterns.
ImageJ Software Analysis: To perform quantitative pixel-based echogenicity evaluation of the ultrasound images.
By systematically comparing these ultrasonographic parameters across the three groups, this study aims to establish standard, reproducible imaging criteria. The primary objective is to determine which specific ultrasound modalities, or combinations thereof, offer the highest diagnostic accuracy in differentiating lymphedema from lipedema in clinical practice.
- Conditions
- Lymphedema, Lipedema
- Being tested
- Multimodal Ultrasound Assessment
- Keywords
- Multimodal Ultrasonography, Strain Elastography, Differential Diagnosis, Power Doppler, ImageJ Analysis, Subcutaneous Tissue
- Medical subject headings
- Lymphedema, Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Ultrasound AssessmentDiagnostic test
Also called B-mode Ultrasonography, Strain Elastography, Power Doppler, ImageJ Analysis
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Multimodal Ultrasound Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (At the time of ultrasound assessment)
Secondary outcomes (3)
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.
Measured: Day 1 (At the time of ultrasound assessment)
Quantitative Echogenicity Analysis
Pixel-based quantitative evaluation of tissue echogenicity from ultrasound images, analyzed using ImageJ software to establish objective imaging biomarkers.
Measured: Day 1 (At the time of ultrasound assessment)
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).
Measured: Day 1 (Baseline clinical evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start15 Sep 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Guc, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489248
- Sponsor's protocol ID
- 2025-564
- Status last verified
- Nov 2026
- First submitted
- 19 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly to maintain participant confidentiality and in accordance with the policies of the institutional ethics committee. However, the study protocol and statistical analysis plan may be available upon reasonable request to the principal investigator.
Publications
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.
PubMed 41303192Mortimer 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.
PubMed 24590276Rockson SG. Lymphedema. Am J Med. 2001 Mar;110(4):288-95. doi: 10.1016/s0002-9343(00)00727-0.
PubMed 11239847
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07489248
- Acronym / sponsor ID
- 2025-564
- Conditions
- Lymphedema, Lipedema
- Keywords
- Multimodal Ultrasonography, Strain Elastography, Differential Diagnosis, Power Doppler, ImageJ Analysis, Subcutaneous Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lymphedema and lipedema are distinct pathological entities that often present with similar clinical features, particularly in the lower extremities. Accurate differential diagnosis is crucial for appropriate therapeutic intervention. While modalities like lymphoscintigraphy serve as standard diagnostic tools for lymphedema, they are invasive and not universally accessible. High-resolution ultrasonography provides a practical, non-invasive alternative for tissue assessment.
This cross-sectional, observational study will recruit participants and categorize them into three groups: a lymphedema group, a lipedema group, and a healthy control group. Comprehensive multimodal ultrasound evaluations will be performed on all participants. The assessment protocol includes:
B-mode Ultrasonography: To measure the thickness of the dermis and subcutaneous tissue layers.
Strain Elastography: To evaluate the biomechanical properties and relative stiffness of the affected tissues.
Power Doppler: To assess the local microvascularity and blood flow patterns.
ImageJ Software Analysis: To perform quantitative pixel-based echogenicity evaluation of the ultrasound images.
By systematically comparing these ultrasonographic parameters across the three groups, this study aims to establish standard, reproducible imaging criteria. The primary objective is to determine which specific ultrasound modalities, or combinations thereof, offer the highest diagnostic accuracy in differentiating lymphedema from lipedema in clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lymphedema Group | – | Diagnostic Test: Multimodal Ultrasound AssessmentPatients 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. |
| Lipedema Group | – | Diagnostic Test: Multimodal Ultrasound AssessmentPatients 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. |
| Healthy Control Group | – | Diagnostic Test: Multimodal Ultrasound AssessmentHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Individuals aged 18 to 65 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Ultrasound AssessmentAlso: B-mode Ultrasonography, Strain Elastography, Power Doppler, ImageJ AnalysisA 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. | Diagnostic test | Healthy Control Group, Lipedema Group, Lymphedema Group |
Primary outcome
Dermal and Subcutaneous Tissue Thickness
Time frame: Day 1 (At the time of ultrasound assessment)
Measurement of the dermal and subcutaneous tissue layers in millimeters (mm) using high-resolution B-mode ultrasonography to identify anatomical differences between the groups.
3 secondary outcomes
Tissue Stiffness Assessment via Strain Elastography
Time frame: Day 1 (At the time of ultrasound assessment)
Quantitative Echogenicity Analysis
Time frame: Day 1 (At the time of ultrasound assessment)
Visual Analogue Scale (VAS) for Pain
Time frame: Day 1 (Baseline clinical evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 41303192Gerard 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.
- Background: PubMed 24590276Mortimer 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.
- Background: PubMed 11239847Rockson SG. Lymphedema. Am J Med. 2001 Mar;110(4):288-95. doi: 10.1016/s0002-9343(00)00727-0.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to maintain participant confidentiality and in accordance with the policies of the institutional ethics committee. However, the study protocol and statistical analysis plan may be available upon reasonable request to the principal investigator.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Lipedema, run by Kayseri City 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 4 inclusion and 6 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 3 Nov 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?
Dermal and Subcutaneous Tissue Thickness (time frame: Day 1 (At the time of ultrasound assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489248, which also lists 3 linked publications.
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 3 Nov 2026.