NCT07724483

Brief Summary

This study aims to investigate the relationship between lower extremity muscle/tendon characteristics and walking/balance functions in women with lipedema. Lipedema is a condition characterized by abnormal fat accumulation that can lead to walking difficulties and joint problems. We will use ultrasonography to measure muscle thickness and tendon structures, and a pedobarography system to analyze foot pressure distribution during standing and walking. By comparing 45 patients with 45 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 Progress29%
Jul 2026Sep 2026

Study Start

First participant enrolled

July 15, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 17, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

LipedemaPedobarographyMusculoskeletal UltrasoundRectus FemorisGastrocnemiusPosterior TibialisGluteus MediusAchillesSTAR

Outcome Measures

Primary Outcomes (2)

  • Lower Extremity Muscle and Tendon Thickness

    Measurement of thickness (mm) for M. Rectus Femoris, Gastrocnemius Medialis, Tibialis Posterior, and Gluteus Medius muscles, and the Patellar tendon via B-mode Ultrasonography (Esaote MyLab Seven).

    At baseline (Day 0)

  • Tendon Cross-Sectional Area (CSA)

    Measurement of cross-sectional area (mm\^2) for Patellar, Achilles, and Tibialis Posterior tendons using B-mode Ultrasonography (Esaote MyLab Seven).

    At baseline (Day 0)

Secondary Outcomes (5)

  • Static Pedobarographic Weight Distribution

    At baseline (Day 0)

  • Center of Pressure (COP) Sway Area

    At baseline (Day 0)

  • Center of Pressure (COP) Sway Velocity

    At baseline (Day 0)

  • Dynamic Peak Plantar Pressures

    At baseline (Day 0)

  • Clarke's Angle

    At baseline (Day 0).

Other Outcomes (5)

  • Rapprich Lipedema Symptomatic Assessment Score

    At baseline (Day 0)

  • LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)

    At baseline (Day 0)

  • Foot Posture Index-6 (FPI-6) Score

    At baseline (Day 0)

  • +2 more other outcomes

Study Arms (2)

Lipedema

Patients Diagnosed Lipedema

Healthy Volunteer

Healthy Volunteers thoose age- and BMI-matched

Eligibility Criteria

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

Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers

You may qualify if:

  • Female patients aged 18-65 years and diagnosed with lipedema by a clinician.
  • To agree to participate in the research.

You may not qualify if:

  • Positivity of Stemmer's sign (inability to compress the skin between the proximal phalanges of the 2nd and 3rd fingers)
  • Patients with Heart Failure
  • Patients with Chronic Kidney Disease
  • Motor neuron diseases or myositis
  • Diseases causing myositis
  • Patients diagnosed with polyneuropathy
  • Patients with motor-involved L3, L4, L5, or S1 radiculopathy
  • Those unable to ambulate independently
  • Those who cannot tolerate the assessments
  • Pregnant women
  • Congenital or traumatic lower extremity disorders (e.g., developmental hip dysplasia, previous lower extremity fractures with orthopaedic implants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Pendik Research and Training Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (19)

  • 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
  • Yalfani A, Ahmadi M, Asgarpoor A. The effect of kinetic factors of dynamic knee valgus on patellofemoral pain: A systematic review and meta-analysis. J Bodyw Mov Ther. 2024 Jan;37:246-253. doi: 10.1016/j.jbmt.2023.11.001. Epub 2023 Nov 14.

    PMID: 38432813BACKGROUND
  • Linsmayer D, Neidlinger PK, Braus DF. [Rheumatism and the mind-A mini review]. Orthopade. 2019 Nov;48(11):957-962. doi: 10.1007/s00132-019-03812-8. German.

    PMID: 31559467BACKGROUND
  • Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.

    PMID: 33124947BACKGROUND
  • Amato AC. Chondromalacia in Lipedema: The Sarcopenic-Valgus Cascade That Keeps Getting Missed. Cureus. 2025 Oct 24;17(10):e95299. doi: 10.7759/cureus.95299. eCollection 2025 Oct.

    PMID: 41287673BACKGROUND
  • Faerber G, Cornely M, Daubert C, Erbacher G, Fink J, Hirsch T, Mendoza E, Miller A, Rabe E, Rapprich S, Reich-Schupke S, Stucker M, Brenner E. S2k guideline lipedema. J Dtsch Dermatol Ges. 2024 Sep;22(9):1303-1315. doi: 10.1111/ddg.15513. Epub 2024 Aug 27.

    PMID: 39188170BACKGROUND
  • Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.

    PMID: 31544340BACKGROUND
  • Guven M, Kocadal O, Akman B, Poyanli OS, Kemah B, Atay EF. Proximal femoral nail shows better concordance of gait analysis between operated and uninjured limbs compared to hemiarthroplasty in intertrochanteric femoral fractures. Injury. 2016 Jun;47(6):1325-31. doi: 10.1016/j.injury.2016.03.009. Epub 2016 Mar 12.

    PMID: 27017452BACKGROUND
  • Lorkowski J, Zarzycki D. [Clinical use of pedobarographic examination--own experience and review of literature]. Przegl Lek. 2006;63 Suppl 5:28-32. Polish.

    PMID: 17469520BACKGROUND
  • Lorkowski J, Gawronska K. Pedobarography in Physiotherapy: A Narrative Review on Current Knowledge. Adv Exp Med Biol. 2022;1375:13-22. doi: 10.1007/5584_2021_636.

    PMID: 33914289BACKGROUND
  • Neville C, Meyers K, Hojnowski L. Ultrasound assessment of the tibialis posterior tendon. J Orthop Sports Phys Ther. 2010 Oct;40(10):667. doi: 10.2519/jospt.2010.0417. No abstract available.

    PMID: 20885025BACKGROUND
  • Johnson AW, Bruening DA, Violette VA, Perkins KV, Thompson CL, Ridge ST. Ultrasound Imaging Is Reliable for Tibialis Posterior Size Measurements. J Ultrasound Med. 2020 Dec;39(12):2305-2312. doi: 10.1002/jum.15340. Epub 2020 May 15.

    PMID: 32412115BACKGROUND
  • Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.

    PMID: 25029916BACKGROUND
  • Sheptulina AF, Yafarova AA, Mamutova EM, Drapkina OM. Sonographic Features of Rectus Femoris Muscle in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease and Their Correlation with Body Composition Parameters and Muscle Strength: Results of a Single-Center Cross-Sectional Study. Biomedicines. 2024 Jul 28;12(8):1684. doi: 10.3390/biomedicines12081684.

    PMID: 39200149BACKGROUND
  • Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

    PMID: 32941253BACKGROUND
  • Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.

    PMID: 28703496BACKGROUND
  • 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
  • WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.

    PMID: 14830102BACKGROUND
  • 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

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

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
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 24, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations