An observational study in Lipedema, Hypermobility Syndrome (Disorder) and Pes Planus, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Marmara University · Observational
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.
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 32 is below 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 presenting to the Physical Medicine and Rehabilitation outpatient clinics at Marmara University Pendik Training and Research Hospital will be screened for eligibility. The study population will include women clinically diagnosed with lipedema according to established diagnostic criteria, as well as age- and BMI-matched female patients with nonspecific foot pain who will serve as the control group.
General Inclusion Criteria (Apply to All Participants)
Additional eligibility criteria for Lipedema Group
- Clinical diagnosis of lipedema according to Halk and Damstra criteria.
Additional eligibility criteria for Control group:
Exclusion Criteria (Apply to all participants)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants diagnosed with lipedema based on established clinical criteria, including characteristic bilateral lower-extremity adipose tissue enlargement, pain or tenderness on palpation, easy bruising, and preservation of foot anatomy. Diagnosis is confirmed by a physiatrist or relevant specialist through medical history and physical examination. These participants will undergo radiographic foot assessment, hypermobility evaluation, and functional testing as part of the study protocol.
Age- and BMI-matched female participants presenting with nonspecific foot pain but without a diagnosis or clinical suspicion of lipedema, lymphedema, connective tissue disorders, or systemic inflammatory disease. These individuals will undergo the same radiographic, hypermobility, and functional assessments as the lipedema group, allowing for direct comparison of foot morphology and joint mobility parameters.
Meary angle (Degrees)
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.
Time frame: Day 1
Calcaneal Inclination Angle (Degrees)
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.
Time frame: Day 1
Beighton Score (0-9)
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.
Time frame: Day 1
Lower Extremity Functional Scale (LEFS) Score
The LEFS questionnaire assesses lower-extremity functional status across daily activities. Scores range from 0 to 80, with higher scores indicating better function.
Time frame: Day 1
Foot Function Index (FFI) Total Score
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.
Time frame: Day 1
Visual Analog Scale (VAS) for Pain (0-100 mm)
Pain severity in both lower extremities will be assessed in three conditions: VAS-Movement VAS-Rest VAS-Night Higher values indicate greater pain intensity.
Time frame: Day 1
Physical Activity Level (IPAQ-Short Form)
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.
Time frame: Day 1
Lower Extremity Volumetric Measurements (cm or mL) - Lipedema Group Only
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.
Time frame: Day 1
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD and supporting documents will be available 6 months after publication of the main results and remain accessible for at least 5 years following publication.
Access criteria: Qualified researchers may request access to the de-identified dataset and supporting documentation by submitting a brief research proposal and data access agreement to the corresponding investigator (Gökçenur Yalçın, M.D., Department of Physical Medicine and Rehabilitation, Marmara University, Istanbul, Turkey). Data will be shared via a secure institutional data repository upon approval by the principal investigator and the Marmara University Ethics Committee.
No publications or documents are linked to this record.
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