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

Completed

• Conditions: Lipedema; Chronic Venous Insufficiency
• Interventions: 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.

• Registration Number: NCT06238791
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-05
• Status Verified: 2024-01
• Primary Completion: 2024-01-24
• Study Completion: 2024-01-24
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic venous disease group	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	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.	-

Primary Outcome Measures

Name	Time	Method
The presence of foot deformity	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.
Plantar pressure distribution	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 Outcome Measures

Name	Time	Method
Ankle range of motion	baseline of study	Ankle dorsi- and plantar-flexion range of motion will be measured using a universal goniometer.
Foot posture	baseline of study	The foot posture will be evaluated with the Foot Posture Index.
Local tissue water percentage	baseline of study	Local tissue water percentages will be evaluated with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device.

Trial Locations

Locations (1)

Ankara Medipol University- Hacettepe University; 🇹🇷 Ankara, Turkey