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

January 31, 2024 updated by: Zilan Bazancir Apaydın, Hacettepe University

Static Plantar Pressure Distribution and Presence of Foot Deformities in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Medipol University- Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline of study
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.
baseline of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle range of motion
Time Frame: baseline of study
Ankle dorsi- and plantar-flexion range of motion will be measured using a universal goniometer.
baseline of study
Foot posture
Time Frame: baseline of study
The foot posture will be evaluated with the Foot Posture Index.
baseline of study
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.
baseline of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 - 1151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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