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Clinical Trials/NCT07294014
NCT07294014RecruitingNot Applicable

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

Marmara University1 site in 1 country32 target enrollmentStarted: January 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
32
Locations
1
Primary Endpoint
Meary angle (Degrees)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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

  • Physical Activity Level (IPAQ-Short Form)(Day 1)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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