Health TrialsbyHealthPanel

Assessment of Venous Insufficiency and Clinical Features in Lipedema

ConditionsLipedemaVenous InsufficiencyVenous DiseaseDisability Physical
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will consist of adult female patients diagnosed with lipedema. Participants with lipedema will be recruited from the outpatient physical medicine and rehabilitation clinic. All participants will undergo clinical assessment and lower extremity venous Doppler ultrasonography.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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 intervention

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

  • Lower Extremity Functional Scale

    Other intervention

    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.

  • Short Form-12

    Other intervention

    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.

  • Lower Extremity Circumference at Standardized Anatomical Landmarks (cm)

    Other intervention

    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 intervention

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

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: Patient6 interventions

Trial outcomes

Primary outcomes

1

Presence of Venous Reflux on Doppler Ultrasonography

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.

Time frame
Baseline

Secondary outcomes

1

Pain Severity (NRS)

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.

Time frame
Baseline
2

Lower Extremity Function (LEFS)

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.

Time frame
Baseline
3

Health-Related Quality of Life (SF-12)

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.

Time frame
Baseline
4

Lower Extremity Circumference Measurements

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Lead sponsor

Source ClinicalTrials.gov
Apply now