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

21 de julho de 2026 atualizado 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

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

90

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: M. Selim Eryılmaz, Res. Asst.
  • Número de telefone: +90 542 48 48 329
  • E-mail: selimerylmz@gmail.com

Locais de estudo

    • Pendik
      • Istanbul, Pendik, Turquia (Türkiye), 34899
        • Recrutamento
        • Marmara University School of Medicine Pendik Research and Training Hospital
        • Contato:
          • Canan Sanal, Assoc. Prof.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Lower Extremity Muscle and Tendon Thickness
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Static Pedobarographic Weight Distribution
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Rapprich Lipedema Symptomatic Assessment Score
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: At baseline (Day 0)
Evaluation of functional exercise capacity measured in meters
At baseline (Day 0)
Subcutaneous Fat Tissue Thickness
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de julho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

15 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de julho de 2026

Primeira postagem (Real)

24 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • MARPODUSG
  • PODUSG (Outro identificador: Marmara University)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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