Assessment of Venous Insufficiency and Clinical Features in Lipedema

NCT07603076 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Lipedema
  • Venous Insufficiency
  • Venous Disease
  • Disability Physical

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

Circumference Measurements

Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement

OTHER

Clinical Staging

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

Sponsors & Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    lead OTHER

Principal Investigators

  • Feyza Yücel, Assoc. Prof. · Sultan 2.Abdülhamid Han Research and Training Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2026-07-01
Completion
2026-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603076 on ClinicalTrials.gov