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CompletedNCT06238791Updated Feb 2, 2024

Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

An observational study in Chronic Venous Insufficiency and Lipedema, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
29
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.

02

Conditions studied

  • Chronic Venous Insufficiency
  • Lipedema

Keywords

  • Foot deformity
  • venous insufficiency
  • pressure
  • Lipedema
03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 29 is below the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients were divided into two groups: Patients with only CVD and patients with CVD accompanied lipedema.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosed with CVD or CVD combined with lipedema,
  • The clinic (C) score of clinical, etiological, anatomical, pathophysiological (CEAP) classification was C1, C2 or C3 (C1: telangiectasia-reticular vein; C2: varicose vein; C3: edema)

Exclusion criteria

Exclusion Criteria:

  • C4, C5 or C6 (presence of skin changes or ulcer) in C score of CEAP classification
  • undergone lower extremity orthopedic surgery within the last year,
  • have peripheral artery disease
  • patients who could not mobilize independently
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • Chronic venous disease group

    Other: Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.

  • Chronic venous disease and lipedema group

    Other: Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.

Interventions

  • OtherPresence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.

    Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease and lipedema.

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What researchers measure

Primary outcomes

  1. The presence of foot deformity

    The presence of foot deformity including hallux valgus, hallux limitus or rigidus, pes planus, pes cavus, toe deformities will be evaluated by inspection. In the presence of hallux valgus, its stage will be evaluated by measuring the angle using a universal goniometer, and in the presence of pes planus, the severity of pes planus will be determined by performing the navicular drop test.

    Time frame: baseline of study

  2. Plantar pressure distribution

    Plantar pressure distribution (PPD) will be evaluated with EsCoSCAN® (EsCo Orthopädie Service GmbH, Germany) pedobarography. The plantar pressure in both feet will be evaluated with the force platform while standing, and the average pressure distribution percentage for each foot will be recorded.

    Time frame: baseline of study

Secondary outcomes

  1. Ankle range of motion

    Ankle dorsi- and plantar-flexion range of motion will be measured using a universal goniometer.

    Time frame: baseline of study

  2. Foot posture

    The foot posture will be evaluated with the Foot Posture Index.

    Time frame: baseline of study

  3. Local tissue water percentage

    Local tissue water percentages will be evaluated with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device.

    Time frame: baseline of study

07

Study locations

1 site
  • Ankara Medipol University- Hacettepe University
    Ankara, Turkey
08

References and documents

Publications

  • Uhl JF, Chahim M, Allaert FA. Static foot disorders: a major risk factor for chronic venous disease? Phlebology. 2012 Feb;27(1):13-8. doi: 10.1258/phleb.2011.010060. Epub 2011 Jul 4. PubMed 21727156 ↗
  • Forner-Cordero I, Szolnoky G, Forner-Cordero A, Kemeny L. Lipedema: an overview of its clinical manifestations, diagnosis and treatment of the disproportional fatty deposition syndrome - systematic review. Clin Obes. 2012 Jun;2(3-4):86-95. doi: 10.1111/j.1758-8111.2012.00045.x. Epub 2012 Aug 3. PubMed 25586162 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2023 to primary completion in Jan 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2024
First posted
Feb 2, 2024
StartActual
Oct 5, 2023
Primary completionActual
Jan 24, 2024
CompletionActual
Jan 24, 2024
Last update
Feb 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06238791
Responsible party
Zilan Bazancir Apaydın (Asst. Prof., Hacettepe University) — Principal investigator
First posted
Feb 2, 2024
Start date
Oct 5, 2023
Primary completion
Jan 24, 2024
Completion
Jan 24, 2024
Last update
Feb 2, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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