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Completed

NCT Number: NCT06238791

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

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.

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Key information

Conditions

Chronic Venous Insufficiency Cardiovascular Diseases Connective Tissue Diseases Foot Deformities Lipedema Musculoskeletal Diseases Skin and Connective Tissue Diseases Vascular Diseases Venous Insufficiency

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Medipol University- Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

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.

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 and lipedema.

Primary outcomes

  1. The presence of foot deformity

    Time frame: baseline of study

    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.

  2. Plantar pressure distribution

    Time frame: baseline of study

    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.

Secondary outcomes

  1. Ankle range of motion

    Time frame: baseline of study

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

  2. Foot posture

    Time frame: baseline of study

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

  3. Local tissue water percentage

    Time frame: baseline of study

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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Static Plantar Pressure Distribution and Presence of Foot Deformities in Patients With Lipedema and Chronic Venous Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

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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