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

NCT ID: NCT07294014

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-04-01

Brief Summary

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.

Detailed Description

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.

Conditions

Lipedema; Hypermobility Syndrome (Disorder); Pes Planus; Joint Hypermobility

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lipedema group

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.

No interventions assigned to this group

Control group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gökçenur Yalçın, M.D., PMR Specialist

Role: CONTACT

gokce_cihaner@hotmail.com

+90 216 414 05 45

Facility Contacts

Gökçenur Yalçın

Role: primary

gokce_cihaner@hotmail.com

+90 216 625 45 45

Other Identifiers

Marmara-FTR-GNY-02

Identifier Type: -

Identifier Source: org_study_id