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

NCT07294014 | Recruiting

• 1 other identifier: Marmara-FTR-GNY-02
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lipedema; mypermobility; foot function; pes planus; joint hyper mobility; foot morphology; Meary angle; calcaneal inclination angle

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1

Secondary Outcomes (5)

• Beighton Score (0-9)

  Day 1

• Lower Extremity Functional Scale (LEFS) Score

  Day 1

• Foot Function Index (FFI) Total Score

  Day 1

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

  Day 1

• Physical Activity Level (IPAQ-Short Form)

  Day 1

Other Outcomes (1)

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

  Day 1

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lipedema; Flatfoot; Joint Instability

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases

Central Study Contacts

Gökçenur Yalçın, M.D., PMR Specialist

CONTACT

+90 216 414 05 45; gokce_cihaner@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

TU (1)