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RECRUITING
NCT07603076

Assessment of Venous Insufficiency and Clinical Features in Lipedema

Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

View on ClinicalTrials.gov

Summary

Lipedema is a chronic adipose tissue disorder characterized by disproportionate fat accumulation, pain, tenderness, edema, and functional impairment. Venous symptoms such as heaviness, swelling, and discomfort are frequently reported in individuals with lipedema; however, the relationship between venous Doppler ultrasonography findings and lipedema-related clinical manifestations remains insufficiently investigated. This cross-sectional controlled study aims to evaluate venous insufficiency parameters in patients with lipedema using Doppler ultrasonography and to examine their associations with pain severity, lower extremity function, disease severity, and quality of life.

Official title: Evaluation of Venous Insufficiency and Its Association With Clinical Features in Patients With Lipedema: A Cross-Sectional Study

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

82

Start Date

2026-06-20

Completion Date

2026-08-01

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Venous Doppler Ultrasonography

Participants will undergo lower extremity venous Doppler ultrasonography to evaluate venous insufficiency findings, including venous reflux characteristics, affected venous segments, and venous diameters in the superficial and deep venous systems.

OTHER

Numeric Rating Scale

Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).

OTHER

Lower Extremity Functional Scale

Functional status will be assessed using the Lower Extremity Functional Scale. The total score ranges from 0 to 80, with higher scores indicating better lower extremity function and lower disability levels.

OTHER

Short Form-12

Health-related quality of life will be assessed using the SF-12 questionnaire, including the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores. Scores range from 0 to 100, with higher scores indicating better perceived health status and quality of life.

OTHER

Lower Extremity Circumference at Standardized Anatomical Landmarks (cm)

Circumference of both lower extremities will be measured using a non-stretch tape measure at the ankle, calf, knee, and thigh according to standardized anatomical landmarks. Measurements will be recorded in centimeters.

OTHER

Clinical Staging

Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.

Locations (1)

Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)