NCT07725146

Brief Summary

Lipedema is a chronic disease characterized by abnormal fat accumulation, primarily in the lower extremities, affecting women. This study aims to evaluate the validity and reliability of the Turkish version of the Rapprich Lipedema Symptomatic Assessment Questionnaire, which was originally developed by Rapprich et al. in 2010. Since a validated Turkish version is currently unavailable, this research will provide a standardized tool for clinicians to assess symptomatic severity in Turkish-speaking lipedema patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Mar 2027

Study Start

First participant enrolled

July 17, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

LipedemaRapprich QuestionnaireSymptom AssessmentTurkishCultural AdaptationAdipose Tissue DiseasesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Internal Consistency (Cronbach's Alpha)

    Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.

    At baseline (Day 0).

Secondary Outcomes (2)

  • Test-Retest Reliability (ICC)

    Baseline and 14 days

  • Criterion Validity (Correlation with SF-36).

    At baseline (Day 0)

Study Arms (3)

Stage I Lipedema

60 female patients diagnosed with Stage I lipedema

Other: QuestionnairesOther: Physical Examination and Functional Testing

Stage II Lipedema

60 female patients diagnosed with Stage II lipedema

Other: QuestionnairesOther: Physical Examination and Functional Testing

Stage III Lipedema

60 female patients diagnosed with Stage III

Other: QuestionnairesOther: Physical Examination and Functional Testing

Interventions

Turkish version of Rapprich Lipedema Symptomatic Assessment Questionnaire: A 15-item scale used to evaluate the severity of lipedema symptoms (such as pain, tension, tenderness, bruising, and heaviness) on a 0-10 point rating scale. Short Form-36 (SF-36) Health Survey: A widely used, validated scale to assess the general health status and quality of life across eight sub-dimensions, used in this study for criterion validity

Stage I LipedemaStage II LipedemaStage III Lipedema

* Anthropometric and Vital Measurements: Recording of demographic data (age, height, weight, BMI), as well as arterial blood pressure and pulse rate. * Lipedema-Specific Assessment: Clinical determination of the lipedema stage (Stages I-III) and type (Types I-V). * Morphometric Measurements: Measurement of waist and hip circumferences (for waist-to-hip ratio) and actual leg length. * Lower Extremity Volume Calculation: Circular circumference measurements taken at 4 cm intervals starting from the ankle to calculate the total volume of both lower extremities. * 6-Minute Walk Test (6MWT): A functional test to evaluate the total walking distance and heart rate response, assessing the patient's functional capacity.

Stage I LipedemaStage II LipedemaStage III Lipedema

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of 180 female patients aged 18 to 75 years diagnosed with Stage I, II, or III lipedema, recruited from the Physical Medicine and Rehabilitation clinics of the participating hospitals.

You may qualify if:

  • Female patients aged 18-75.
  • Diagnosed with lipedema by a clinician.
  • Willingness to participate and sign the informed consent form.

You may not qualify if:

  • Positive Stemmer sign or presence of advanced-stage lymphedema.
  • Diagnosis of Heart Failure.
  • Chronic Kidney Disease.
  • Pregnancy.
  • BMI \> 50 kg/m².

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sultan 2. Abdülhamid Han Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.

Istanbul, Kadıköy, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Training and Research Hospital, Physical Medicine and Rehabilitation Department, Istanbul, Turkey.

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Mortada H, Alhithlool AW, AlBattal NZ, Shetty RK, Al-Mekhlafi GA, Hong JP, Alshomer F. Lipedema: Clinical Features, Diagnosis, and Management. Arch Plast Surg. 2025 May 15;52(3):185-196. doi: 10.1055/a-2530-5875. eCollection 2025 May.

    PMID: 40386000BACKGROUND
  • Amato ACM, Amato FCM, Benitti DA, Dos Santos RV. Translation, cultural adaptation, and validation of a lipedema symptoms questionnaire. J Vasc Bras. 2020 Aug 31;19:e20200049. doi: 10.1590/1677-5449.200049.

    PMID: 34178078BACKGROUND
  • van la Parra RFD, Deconinck C, Pirson G, Servaes M, Fosseprez P. Lipedema: What we don't know. J Plast Reconstr Aesthet Surg. 2023 Sep;84:302-312. doi: 10.1016/j.bjps.2023.05.056. Epub 2023 May 30.

    PMID: 37390539BACKGROUND
  • Rapprich S, Dingler A, Podda M. Liposuction is an effective treatment for lipedema-results of a study with 25 patients. J Dtsch Dermatol Ges. 2011 Jan;9(1):33-40. doi: 10.1111/j.1610-0387.2010.07504.x. Epub 2010 Sep 7. English, German.

    PMID: 21166777BACKGROUND

MeSH Terms

Conditions

Lipedema

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Canan Şanal, Assoc. Prof.

    Marmara University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Canan Şanal, Assoc. Prof.

CONTACT

M. Selim Eryılmaz, Res. Asst.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

July 17, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations