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NCT Number: NCT07294014

Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema

Lipedema is a chronic adipose tissue disorder that commonly leads to joint laxity, hypermobility, and functional limitations, yet its impact on foot morphology has not been systematically examined. This case-control study aims to investigate whether patients with lipedema exhibit a higher prevalence of generalized joint hypermobility and foot structural abnormalities-specifically pes planus-compared with age- and BMI-matched controls. Using radiographic measurements (Meary angle and calcaneal inclination angle), clinical hypermobility assessment, and validated functional scales, the study seeks to determine the relationship between lipedema, hypermobility, and foot function.

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Key information

About this study

Lipedema is a progressive adipose tissue disorder characterized by disproportionate subcutaneous fat accumulation, predominantly in the lower extremities. Patients frequently experience pain, easy bruising, reduced quality of life, and musculoskeletal complications such as joint laxity and hypermobility. Although previous studies have suggested an increased prevalence of hypermobility in individuals with lipedema, the potential impact of these biomechanical changes on foot posture and foot function remains insufficiently studied.

This case-control, single-session, single-blind (participant-blinded) study is designed to evaluate structural and functional foot characteristics in women diagnosed with lipedema, compared with age- and BMI-matched controls presenting with nonspecific foot pain. The primary radiographic variables include the Meary angle and calcaneal inclination angle measured on standardized lateral foot radiographs. These measurements provide objective quantification of midfoot alignment and arch height, enabling detection of pes planus and related morphological deviations.

In addition to radiographic assessment, the study incorporates established clinical tools to quantify joint hypermobility, foot function, pain severity, and physical activity levels. The Beighton score will be used to determine generalized joint hypermobility. Functional and symptomatic status will be evaluated using validated questionnaires, including the Foot Function Index (FFI), Lower Extremity Functional Scale (LEFS), Visual Analog Scale (VAS) for pain, and the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

Sociodemographic and clinical data-including disease duration, comorbidities, and lower extremity volumetric measurements-will be systematically recorded to identify potential associations between patient characteristics and foot morphology. The study aims to clarify whether the presence of hypermobility in lipedema contributes to alterations in medial longitudinal arch structure and whether these changes are more prevalent than in a matched control population.

The findings are expected to provide insight into the biomechanical consequences of lipedema, support more accurate clinical assessment, and potentially guide rehabilitative strategies targeting lower extremity alignment and function in this patient group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria (Apply to All Participants)

  • Female participants
  • Age 18 years or older
  • Able to read and write (literacy requirement)
  • Availability of bilateral lateral foot radiographs obtained within the past 1 year in the hospital PACS system
  • Willing and able to provide written and verbal informed consent

Additional eligibility criteria for Lipedema Group

  • Clinical diagnosis of lipedema according to Halk and Damstra criteria.

Additional eligibility criteria for Control group:

  • Female patients presenting with nonspecific foot pain
  • Similar age and BMI range as the lipedema group
  • No clinical diagnosis or suspicion of lipedema

Exclusion criteria

(Apply to all participants)

  • Pregnancy
  • Illiteracy
  • Inability or unwillingness to provide written and verbal informed consent
  • History of lower extremity fracture, trauma, or orthopedic surgery
  • Diagnosis of diabetes mellitus
  • Known rheumatologic disease
  • Known polyneuropathy or peripheral nerve injury affecting the lower extremities

Treatment and study plan

Primary outcomes

  1. Meary angle (Degrees)

    Time frame: Day 1

    The Meary angle (talo-first metatarsal angle) will be measured on standardized lateral foot radiographs to evaluate medial longitudinal arch alignment. Increased angles indicate midfoot collapse and are used to identify pes planus. Higher values represent greater deviation from normal alignment.

  2. Calcaneal Inclination Angle (Degrees)

    Time frame: Day 1

    The calcaneal inclination angle will be measured on lateral foot radiographs to assess arch height. Lower angles indicate reduced arch height, consistent with pes planus. Measurements are obtained using established radiographic guidelines.

Secondary outcomes

  1. Beighton Score (0-9)

    Time frame: Day 1

    Generalized joint hypermobility will be evaluated using the Beighton Score, a validated 9-point scale assessing joint laxity in the fingers, elbows, knees, and spine. A score ≥4 indicates generalized hypermobility.

  2. Lower Extremity Functional Scale (LEFS) Score

    Time frame: Day 1

    The LEFS questionnaire assesses lower-extremity functional status across daily activities. Scores range from 0 to 80, with higher scores indicating better function.

  3. Foot Function Index (FFI) Total Score

    Time frame: Day 1

    The FFI evaluates foot-related disability and pain using 23 items across three subscales: pain, disability, and activity limitation. Higher scores reflect greater functional impairment.

  4. Visual Analog Scale (VAS) for Pain (0-100 mm)

    Time frame: Day 1

    Pain severity in both lower extremities will be assessed in three conditions:

    VAS-Movement VAS-Rest VAS-Night Higher values indicate greater pain intensity.

  5. Physical Activity Level (IPAQ-Short Form)

    Time frame: Day 1

    Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form. Results will classify participants into low, moderate, or high activity categories based on metabolic equivalent (MET)-minutes per week.

Other outcomes

  1. Lower Extremity Volumetric Measurements (cm or mL) - Lipedema Group Only

    Time frame: Day 1

    Circumferential measurements at standardized anatomical points will be used to calculate volumetric estimates of lower extremity adipose tissue distribution to support characterization of disease severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Gökçenur Yalçın, M.D., PMR Specialist

CONTACT

[email protected]

+90 216 414 05 45

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema: A Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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