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NCT Number: NCT07603076

Assessment of Venous Insufficiency and Clinical Features in Lipedema

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Istanbul, Uskudar, Turkey (Türkiye)

Location status: Recruiting

Location contact

Feyza Yücel, Assoc.Prof.

CONTACT

Şule Dayanç

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous Doppler Ultrasonography

Diagnostic Test

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.

Numeric rating scale

Other

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

Other names: NRS

Lower Extremity Functional Scale

Other

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 names: LEFS

Short Form-12

Other

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 names: SF-12

Lower Extremity Circumference at Standardized Anatomical Landmarks (cm)

Other

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.

Clinical Staging

Other

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

Primary outcomes

  1. Presence of Venous Reflux on Doppler Ultrasonography

    Time frame: Baseline

    Venous reflux will be assessed using lower extremity venous Doppler ultrasonography. The presence of pathological reflux in great saphenous vein will be recorded according to standard venous ultrasound criteria.

Secondary outcomes

  1. Pain Severity (NRS)

    Time frame: Baseline

    Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.

  2. Lower Extremity Function (LEFS)

    Time frame: Baseline

    Lower extremity function will be evaluated using the Lower Extremity Functional Scale (LEFS). Total scores range from 0 to 80, with higher scores indicating better functional status and lower disability levels.

  3. Health-Related Quality of Life (SF-12)

    Time frame: Baseline

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

  4. Lower Extremity Circumference Measurements

    Time frame: Baseline

    Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement and tissue distribution.

  5. Duration of Venous Reflux on Doppler Ultrasonography

    Time frame: Baseline

    Reflux duration (milliseconds) in great saphenous vein will be recorded according to standard venous ultrasound criteria.

  6. Great Saphenous Vein Diameter Measured by Doppler Ultrasonography

    Time frame: Baseline

    The diameter of the great saphenous vein will be measured in millimeters using lower extremity venous Doppler ultrasonography. Measurements will be recorded at predefined anatomical levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Feyza Yücel, Assoc. Prof.

CONTACT

[email protected]

(0216) 542 20 00 ext. +90

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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