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LipedemaPODUSGNCT07724483

Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients

An observational study of Lipedema and Obesity & Overweight, run by Marmara University 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

The primary aim of this study is to evaluate the lower extremity muscle structure, lower extremity alignment, and foot posture in lipedema; secondly, to reveal the chain relationship and biomechanical problems that may be observed in lipedema patients. 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
Lipedema, Obesity & Overweight
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2026to 15 Sep 2026
How long will I take part?
1 Day
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: Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers

Who may be able to join

  • Female patients aged 18-65 years and diagnosed with lipedema by a clinician.
  • To agree to participate in the research.

Who cannot join

  • Positivity of Stemmer's sign (inability to compress the skin between the proximal phalanges of the 2nd and 3rd fingers)
  • Patients with Heart Failure
  • Patients with Chronic Kidney Disease
  • Motor neuron diseases or myositis
  • Diseases causing myositis
  • Patients diagnosed with polyneuropathy
Show all 11Show fewer
  • Patients with motor-involved L3, L4, L5, or S1 radiculopathy
  • Those unable to ambulate independently
  • Those who cannot tolerate the assessments
  • Pregnant women
  • Congenital or traumatic lower extremity disorders (e.g., developmental hip dysplasia, previous lower extremity fractures with orthopaedic implants).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University School of Medicine Pendik Research and Training Hospital

    Istanbul, Pendik, 34899

Other trials in Turkey (Türkiye)

About this study

The primary aim of this study is to evaluate the lower extremity muscle structure, lower extremity alignment, and foot posture in lipedema; secondly, to reveal the chain relationship and biomechanical problems that may be observed in lipedema patients. Lipedema is a condition characterized by abnormal fat accumulation that can lead to walking difficulties and joint problems. We will use ultrasonography to measure muscle thickness and tendon structures, and a pedobarography system to analyze foot pressure distribution during standing and walking. By comparing 50 women diagnosed lipedema with 50 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

Read the detailed description

Lipedema is a disease affecting fat tissues. Fat accumulates abnormally, especially in the hips and lower extremities. It was first described by Worl et al. The cause of the disease is unknown at the current level of scientific knowledge. Lipedema usually occurs in women during adolescence and the third decade. Although there is usually no lymphatic flow dysfunction in these patients, they are often misdiagnosed with lymphedema, but lipedema can cause secondary lymphatic dysfunction, leading to the development of lipolymphedema.

Lipedema is a clinical diagnosis. It is evaluated with appropriate history taking and physical examination. It can be detected by symptoms such as easy bruising, difficulty in losing weight from the legs while losing weight from the trunk, the presence of women with similar conditions in the family, pain on pressure, disproportion between the upper and lower body, pearl-sized nodules on the thighs, and decreased tissue and fascia elasticity on physical examination.

Ultrasonography (USG) muscle thickness measurement is a reliable method for determining regional muscle mass. Previous studies in the literature have evaluated the rectus femoris, gastrocnemius, gluteus medius and posterior tibialis muscles with USG and appropriate measurement techniques have been determined in these studies.

Pedobarography is a technology that evaluates a person's gait, balance, and consequently their locomotor system by examining the pressure distributions on the sole of the foot. It can be used diagnostically in the evaluation of lower extremity pathologies. Pedobarographic examination can provide static, postural, and dynamic evaluation. Static evaluation assesses the plantar pressure distribution during a certain standing time, while postural evaluation examines the pressure distributions in different standing positions. Dynamic evaluation assesses the load distribution on the sole of the foot during walking.

It is known that foot mechanics are affected in patients with lipedema. Considering that the load on the foot is increased in this patient group and that the majority of this load is caused by atypically stored fat, impairment of foot function is inevitable, especially in advanced stages. This is attributed to the valgus position of the knee and the disruption of the medial arch of the foot due to weakness of the knee extensors and hip abductors, and it has also been stated that these alignment problems may be due to gait disorders. Furthermore, it is known that obesity, which may occur simultaneously with lipedema, can lead to additional problems in mobility, and this limited mobility also increases the risk of depression. In addition, predominant sarcopenia in the thigh can be observed in these patients. In this case, weakness of the gluteus medius and quadriceps femoris that may develop contributes to the development of dynamic valgus in the knee. With the development of dynamic valgus, patellar displacement may occur, and as a result, chondromalacia may develop.

Considering the walking problems frequently observed in lipedema patients, it is crucial to address the root causes of these problems, preventing them where possible and detecting them when intervention is required. To achieve this, an assessment of potential problems and identification of related muscle and tendon dysfunctions are necessary to determine their causes. The aim of this study is to evaluate musculoskeletal problems in the lower extremities of lipedema patients, particularly those related to gait and posture, and their functional implications, and to determine the relationship between these functional problems and measurements of muscles and tendons using ultrasonography.

Study Methodology:

Design: Cross-sectional case-control study. Participants: 45 female patients with lipedema and 45 healthy controls. Clinical Evaluation: BMI, waist-hip ratio, leg volume calculation, and Foot Posture Index-6.

Functional Assessment: 6-Minute Walk Test. Questionnaires: Rapprich Lipedema Symptomatic Assessment, LYMPQOL-LEG and Short Form-36 USG Protocol: Measurement of M. Rectus Femoris, Gastrocnemius, Tibialis Posterior, and Gluteus Medius thickness using Esaote MyLab Seven lineer probe [SL1543].

Pedobarography: Static and dynamic 6-phase gait analysis using ACK Medical pedogram system.

Statistical Analysis: Group comparisons and Pearson/Spearman correlation analysis will be performed using SPSS.

Keywords
Lipedema, Pedobarography, Musculoskeletal Ultrasound, Rectus Femoris, Gastrocnemius, Posterior Tibialis, Gluteus Medius, Achilles, STAR
Medical subject headings
Lipedema, Obesity, Overweight

What participants receive

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

Study groups in NCT07724483
Study groupRoleWhat they receive
LipedemaPatients Diagnosed Lipedema
Healthy VolunteerHealthy Volunteers thoose age- and BMI-matched

What is being measured

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

  1. M. Rectus Femoris Muscle Thickness

    Measurement of thickness (mm) for M. Rectus Femoris with B-mode Ultrasonography (Esaote MyLab Seven). With the participant's knee fully extended and in a supine position, the transverse section of the image obtained from the midpoint of the distance between the SIAS and the upper edge of the patella was used to measure the RF thickness, excluding the fascial boundaries.

    Measured: At baseline (Day 0)

  2. M. Gastrocnemius Medialis Muscle Thickness

    Measurement of thickness (mm) for Gastrocnemius Medialis via B-mode Ultrasonography (Esaote MyLab Seven). With the participant in the prone position, muscle thickness (distance between superficial and deep fascia) was measured in a longitudinal section at the proximal 1/3 of the muscle, where it is widest.

    Measured: At baseline (Day 0)

  3. M. Tibialis Posterior Muscle Thickness

    Measurement of thickness (mm) for M. Tibialis Posterior via B-mode Ultrasonography (Esaote MyLab Seven). With the participant in the supine position, the muscle running deep within the tibialis anterior, at approximately 30% of the lateral malleolus and between the lateral knee joint space, was identified. The thickness of the muscle was assessed at the midline in the transverse section.

    Measured: At Baseline (Day 0)

  4. M. Gluteus Medius Muscle Thickness

    Measurement of thickness (mm) for M. Gluteus Medius via B-mode Ultrasonography (Esaote MyLab Seven). The participant was positioned in the LD position, with both legs crossed and hips and knees flexed at 30°. The midpoint between the major trochanter and the crista iliaca was located and measured longitudinally. The thickness of the muscle located in the deep compartment was evaluated in the longitudinal section.

    Measured: At Baseline (Day 0)

  5. Clarke's Angle

    Measurement of Clarke's angle (in degrees) derived from the plantar pressure distribution to objectively evaluate the integrity of the medial longitudinal arch.

    Measured: At baseline (Day 0).

  6. Foot Posture Index-6 (FPI-6) Score

    Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment

    Measured: At baseline (Day 0)

  7. Genu Valgum

    In genu valgum examination, the intermalleolar distance was measured while the participant had both knees together, and values greater than 8 cm were considered positive. In participants with an increase in intermalleolar distance, the tibiofemoral angle was measured, and values above 5° were considered genu valgum.

    Measured: At baseline (Day 0)

  8. Genu Recurvatum

    In the genu recurvatum assessment, participants were placed in a supine position with a cushion under their heels, the goniometer was placed on the lateral femoral condyle, the tips of the goniometer were aligned with the greater trochanter and the lateral malleolus, and goniometric knee hyperextension was measured; values above 5° were considered positive.

    Measured: At Baseline (Day 0)

Secondary outcomes (8)
  1. Static Pedobarographic Weight Distribution Left& Right

    Evaluation of the percentage (%) of weight distribution between left and right feet during static standing.

    Measured: At baseline (Day 0)

  2. Static Pedobarographic Weight Distribution Forefoot& Hindfoot

    Evaluation of the percentage (%) of weight distribution between forefoot and hindfoot pressure ratio during static standing.

    Measured: At Baseline (Day 0)

  3. Center of Pressure (COP) Sway Area

    Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.

    Measured: At baseline (Day 0)

  4. Center of Pressure (COP) Sway Velocity

    Measurement of the movement speed (mm/s) of the center of pressure during static standing.

    Measured: At baseline (Day 0)

  5. Dynamic Peak Plantar Pressures

    Measurement of maximum peak pressure (N/cm^2) during 6 gait phases (Heel Strike, Foot Flat, Mid-stance, Heel Off, Toe Off) using the pedogram system.

    Measured: At baseline (Day 0)

  6. Patellar Tendon Cross-Sectional Area (CSA)

    Measurement of cross-sectional area (mm^2) for Patellar tendon using B-mode Ultrasonography (Esaote MyLab Seven). For the patellar tendon, a cross-sectional area (CSA, mm²) was drawn in a transverse section between the lower end of the patella and the midpoint of the tibial tuberosity with the knee flexed at 30°; the tendon thickness was measured in millimeters in a longitudinal section.

    Measured: At baseline (Day 0)

  7. Achilles Tendon Cross-Sectional Area (CSA)

    Measurement of cross-sectional area (mm^2) for Achilles tendon using B-mode Ultrasonography (Esaote MyLab Seven). With the ankle in a 90° neutral position, and the participant in the prone position, CSA (mm²) measurement was performed in a transverse section with the probe positioned at a perfect right angle to the tendon at the level of the medial malleolus, with a dense gel layer underneath.

    Measured: At Baseline (Day 0)

  8. Tibialis Posterior Tendon Cross-Sectional Area (CSA)

    Measurement of cross-sectional area (mm^2) for tibialis posterior tendon using B-mode Ultrasonography (Esaote MyLab Seven). For the tendon, the participant was positioned in the lateral decubitus position, with the side to be evaluated close to the operator and medial to the anterior aspect. Images were acquired through the retromalleolar canal immediately behind the Medial Malleolus. A transverse section was obtained and measured at the point where the tendon wraps around the MM.

    Measured: At Baseline (Day 0)

Timeline

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

  1. First posted24 Jul 2026
  2. Study start15 Jul 2026
  3. Primary completion31 Aug 2026
  4. Study completion15 Sep 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
Case-control
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07724483
Sponsor's protocol ID
MARPODUSG
Other IDs
PODUSG
Acronym
PODUSG
Status last verified
Oct 2026
First submitted
17 Jul 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rapprich S, Dingler A, Podda M. Liposuction is an effective treatment for lipedema-results of a study with 25 patients. J Dtsch Dermatol Ges. 2011 Jan;9(1):33-40. doi: 10.1111/j.1610-0387.2010.07504.x. Epub 2010 Sep 7. English, German.

    PubMed 21166777
  • Yalfani A, Ahmadi M, Asgarpoor A. The effect of kinetic factors of dynamic knee valgus on patellofemoral pain: A systematic review and meta-analysis. J Bodyw Mov Ther. 2024 Jan;37:246-253. doi: 10.1016/j.jbmt.2023.11.001. Epub 2023 Nov 14.

    PubMed 38432813
  • Linsmayer D, Neidlinger PK, Braus DF. [Rheumatism and the mind-A mini review]. Orthopade. 2019 Nov;48(11):957-962. doi: 10.1007/s00132-019-03812-8. German.

    PubMed 31559467
  • Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.

    PubMed 33124947
  • Amato AC. Chondromalacia in Lipedema: The Sarcopenic-Valgus Cascade That Keeps Getting Missed. Cureus. 2025 Oct 24;17(10):e95299. doi: 10.7759/cureus.95299. eCollection 2025 Oct.

    PubMed 41287673
  • Faerber G, Cornely M, Daubert C, Erbacher G, Fink J, Hirsch T, Mendoza E, Miller A, Rabe E, Rapprich S, Reich-Schupke S, Stucker M, Brenner E. S2k guideline lipedema. J Dtsch Dermatol Ges. 2024 Sep;22(9):1303-1315. doi: 10.1111/ddg.15513. Epub 2024 Aug 27.

    PubMed 39188170
  • Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.

    PubMed 31544340
  • Guven M, Kocadal O, Akman B, Poyanli OS, Kemah B, Atay EF. Proximal femoral nail shows better concordance of gait analysis between operated and uninjured limbs compared to hemiarthroplasty in intertrochanteric femoral fractures. Injury. 2016 Jun;47(6):1325-31. doi: 10.1016/j.injury.2016.03.009. Epub 2016 Mar 12.

    PubMed 27017452
  • Lorkowski J, Zarzycki D. [Clinical use of pedobarographic examination--own experience and review of literature]. Przegl Lek. 2006;63 Suppl 5:28-32. Polish.

    PubMed 17469520
  • Lorkowski J, Gawronska K. Pedobarography in Physiotherapy: A Narrative Review on Current Knowledge. Adv Exp Med Biol. 2022;1375:13-22. doi: 10.1007/5584_2021_636.

    PubMed 33914289
  • Neville C, Meyers K, Hojnowski L. Ultrasound assessment of the tibialis posterior tendon. J Orthop Sports Phys Ther. 2010 Oct;40(10):667. doi: 10.2519/jospt.2010.0417. No abstract available.

    PubMed 20885025
  • Johnson AW, Bruening DA, Violette VA, Perkins KV, Thompson CL, Ridge ST. Ultrasound Imaging Is Reliable for Tibialis Posterior Size Measurements. J Ultrasound Med. 2020 Dec;39(12):2305-2312. doi: 10.1002/jum.15340. Epub 2020 May 15.

    PubMed 32412115
  • Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.

    PubMed 25029916
  • Sheptulina AF, Yafarova AA, Mamutova EM, Drapkina OM. Sonographic Features of Rectus Femoris Muscle in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease and Their Correlation with Body Composition Parameters and Muscle Strength: Results of a Single-Center Cross-Sectional Study. Biomedicines. 2024 Jul 28;12(8):1684. doi: 10.3390/biomedicines12081684.

    PubMed 39200149
  • Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

    PubMed 32941253

Questions about this trial

What is this clinical trial studying?

An observational study of Lipedema and Obesity & Overweight, run by Marmara University 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 2 inclusion and 11 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 7 Oct 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?

M. Rectus Femoris Muscle Thickness (time frame: At baseline (Day 0)). The study lists 8 primary outcomes in all. 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 NCT07724483, which also lists 19 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 7 Oct 2026.

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