An observational study in Lipedema and Obesity & Overweight, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Marmara University · Observational
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
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients Diagnosed Lipedema
Healthy Volunteers thoose age- and BMI-matched
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.
Time frame: At baseline (Day 0)
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.
Time frame: At baseline (Day 0)
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.
Time frame: At Baseline (Day 0)
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.
Time frame: At Baseline (Day 0)
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.
Time frame: At baseline (Day 0).
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
Time frame: At baseline (Day 0)
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.
Time frame: At baseline (Day 0)
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.
Time frame: At Baseline (Day 0)
Static Pedobarographic Weight Distribution Left& Right
Evaluation of the percentage (%) of weight distribution between left and right feet during static standing.
Time frame: At baseline (Day 0)
Static Pedobarographic Weight Distribution Forefoot& Hindfoot
Evaluation of the percentage (%) of weight distribution between forefoot and hindfoot pressure ratio during static standing.
Time frame: At Baseline (Day 0)
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.
Time frame: At baseline (Day 0)
Center of Pressure (COP) Sway Velocity
Measurement of the movement speed (mm/s) of the center of pressure during static standing.
Time frame: At baseline (Day 0)
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.
Time frame: At baseline (Day 0)
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.
Time frame: At baseline (Day 0)
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.
Time frame: At Baseline (Day 0)
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.
Time frame: At Baseline (Day 0)
Rapprich Lipedema Symptomatic Assessment Score
A 15-item scale (0-10 points each) assessing the severity of symptoms such as pain, tension, sensitivity, and easy bruising in the legs. Total score ranges from 0 to 150
Time frame: At baseline (Day 0)
LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)
A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices
Time frame: At baseline (Day 0)
6-Minute Walk Test (6MWT) Distance
Evaluation of functional exercise capacity measured in meters. The test was administered in a 30-meter straight corridor, following standard verbal instructions, in accordance with the American Thoracic Society guidelines.
Time frame: At baseline (Day 0)
Subcutaneous Fat Tissue Thickness
Measurement of subcutaneous fat thickness (mm) at standardized regions (anterior thigh, medial thigh, lateral calf, arm, and forearm) via Ultrasonography (Esaote MyLab Seven).
Time frame: At baseline (Day 0)
Waist to Hip Ratio
Waist circumference was measured at the midpoint between the lower edge of the costal margin and the iliac crest; hip circumference was measured at the widest point of the gluteal region, with the participant standing and at the end of normal expiration, using a non-stretching measuring tape according to the World Health Organization protocol.
Time frame: At Baselin (Day 0)
Plan to share: Undecided
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