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Assessment of Venous Insufficiency and Clinical Features in Lipedema

S

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Not yet enrolling

Conditions

Lipedema
Venous Insufficiency
Venous Disease
Disability Physical

Treatments

Other: Clinical Staging
Diagnostic Test: Venous Doppler Ultrasonography
Other: Short Form-12
Other: Numeric Rating Scale
Other: Lower Extremity Functional Scale
Other: Circumference Measurements

Study type

Observational

Funder types

Other

Identifiers

NCT07603076
00000111

Details and patient eligibility

About

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.

Full description

Lipedema is a chronic progressive disorder of subcutaneous adipose tissue that predominantly affects women and is characterized by symmetrical enlargement of the lower extremities, pain, tenderness, easy bruising, and functional limitation. Beyond adipose tissue abnormalities, vascular and microcirculatory alterations have increasingly been implicated in the pathophysiology of the disease. Many individuals with lipedema report symptoms suggestive of venous dysfunction, including leg heaviness, swelling, discomfort, and exercise intolerance. Nevertheless, the clinical significance of venous insufficiency in lipedema has not been fully clarified.This cross-sectional controlled observational study aims to investigate venous insufficiency findings in individuals with lipedema using venous Doppler ultrasonography and to explore their relationship with clinical symptoms and functional status. Venous reflux characteristics, venous diameters, and affected venous segments will be evaluated in the superficial and deep venous systems. These vascular findings will subsequently be analyzed in relation to lipedema severity, pain intensity, lower extremity function, anthropometric measurements, and patient-reported outcomes. By improving the understanding of venous involvement in lipedema, this study may contribute to more comprehensive diagnostic assessment and multidisciplinary management strategies for affected individuals. Patients with lipedema are expected to show more frequent venous insufficiency findings, which may be associated with increased symptom severity and functional limitation.

Enrollment

82 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female participants aged 18 years or older
  • Clinically diagnosed lipedema according to established diagnostic criteria
  • Ability to provide written informed consent
  • Ability to complete clinical assessments and questionnaires

Exclusion criteria

  • History of lower extremity venous surgery or sclerotherapy
  • Known peripheral arterial disease
  • Secondary lymphedema or other causes of lower extremity edema
  • Active infection, cellulitis, or inflammatory disease affecting the lower extremities
  • Pregnancy or postpartum period
  • Neurological, rheumatological, or musculoskeletal disorders significantly affecting lower extremity function
  • Malignancy or severe systemic disease
  • Inability to undergo venous Doppler ultrasonography
  • Inability to understand or complete study assessments and questionnaires

Trial design

82 participants in 1 patient group

Patient
Description:
Patients with lipedema
Treatment:
Other: Circumference Measurements
Other: Lower Extremity Functional Scale
Other: Short Form-12
Other: Numeric Rating Scale
Diagnostic Test: Venous Doppler Ultrasonography
Other: Clinical Staging

Trial contacts and locations

1

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Central trial contact

Feyza Yücel, Assoc. Prof.

Data sourced from clinicaltrials.gov

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