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临床试验/NCT06238791
NCT06238791已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
The presence of foot deformity

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

The presence of foot deformity

时间窗: 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

时间窗: 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.

次要结局

  • Ankle range of motion(baseline of study)
  • Foot posture(baseline of study)
  • Local tissue water percentage(baseline of study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zilan Bazancir Apaydın

Asst. Prof.

Hacettepe University

研究点 (1)

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