Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Illiteracy
Inability or unwillingness to provide written and verbal informed consent
History of lower extremity fracture, trauma, or orthopedic surgery
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 2 trial groupsGroup A: Lipedema group
Group B: Control group
Trial outcomes
Primary outcomes
1
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 12
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 1Secondary outcomes
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 12
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 13
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 14
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 1Other outcomes
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 1Sponsors and contacts
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Source ClinicalTrials.gov