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

21 de julio de 2026 actualizado por: Marmara University
This study aims to investigate the relationship between lower extremity muscle/tendon characteristics and walking/balance functions in women with lipedema. 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 45 patients with 45 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

90

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Canan Şanal, Assoc. Prof.
  • Número de teléfono: +90 533 138 10 32
  • Correo electrónico: canansanal@hotmail.com

Copia de seguridad de contactos de estudio

  • Nombre: M. Selim Eryılmaz, Res. Asst.
  • Número de teléfono: +90 542 48 48 329
  • Correo electrónico: selimerylmz@gmail.com

Ubicaciones de estudio

    • Pendik
      • Istanbul, Pendik, Turquía (Türkiye), 34899
        • Reclutamiento
        • Marmara University School of Medicine Pendik Research and Training Hospital
        • Contacto:
          • Canan Sanal, Assoc. Prof.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Lipedema
Patients Diagnosed Lipedema
Healthy Volunteer
Healthy Volunteers thoose age- and BMI-matched

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lower Extremity Muscle and Tendon Thickness
Periodo de tiempo: At baseline (Day 0)
Measurement of thickness (mm) for M. Rectus Femoris, Gastrocnemius Medialis, Tibialis Posterior, and Gluteus Medius muscles, and the Patellar tendon via B-mode Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)
Tendon Cross-Sectional Area (CSA)
Periodo de tiempo: At baseline (Day 0)
Measurement of cross-sectional area (mm^2) for Patellar, Achilles, and Tibialis Posterior tendons using B-mode Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Static Pedobarographic Weight Distribution
Periodo de tiempo: At baseline (Day 0)
Evaluation of the percentage (%) of weight distribution between left and right feet and the forefoot/hindfoot pressure ratio during static standing
At baseline (Day 0)
Center of Pressure (COP) Sway Area
Periodo de tiempo: At baseline (Day 0)
Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.
At baseline (Day 0)
Center of Pressure (COP) Sway Velocity
Periodo de tiempo: At baseline (Day 0)
Measurement of the movement speed (mm/s) of the center of pressure during static standing.
At baseline (Day 0)
Dynamic Peak Plantar Pressures
Periodo de tiempo: At baseline (Day 0)
Measurement of maximum peak pressures (N/cm^2) across 6 gait phases (Heel Strike, Foot Flat, Mid-stance, Heel Off, Toe Off) using the pedogram system.
At baseline (Day 0)
Clarke's Angle
Periodo de tiempo: At baseline (Day 0).
Measurement of Clarke's angle (in degrees) derived from the plantar pressure distribution to objectively evaluate the integrity of the medial longitudinal arch.
At baseline (Day 0).

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Rapprich Lipedema Symptomatic Assessment Score
Periodo de tiempo: At baseline (Day 0)
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
At baseline (Day 0)
LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)
Periodo de tiempo: At baseline (Day 0)
A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices
At baseline (Day 0)
Foot Posture Index-6 (FPI-6) Score
Periodo de tiempo: At baseline (Day 0)
Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment
At baseline (Day 0)
6-Minute Walk Test (6MWT) Distance
Periodo de tiempo: At baseline (Day 0)
Evaluation of functional exercise capacity measured in meters
At baseline (Day 0)
Subcutaneous Fat Tissue Thickness
Periodo de tiempo: At baseline (Day 0)
Measurement of subcutaneous fat thickness (mm) at standardized regions (anterior thigh, medial thigh, lateral calf, arm, and forearm) via Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de julio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

15 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MARPODUSG
  • PODUSG (Otro identificador: Marmara University)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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