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临床试验/NCT04159922
NCT04159922已完成不适用

Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Score of the Bortner self-questionnaire

研究概览

简要总结

Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.

It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.

Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.

It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • diagnosis of type 2 diabetes
  • patient > 18 years old
  • with a diabetic foot wound
  • person who has expressed non-opposiyion to participation in the study

排除标准

  • a person who is not affiliated to national health insurance
  • person subject to legal protection (curatorship, guardianship)
  • person under limited judicial protection
  • pregnant, parturient or breastfeeding woman
  • adult unable to consent

研究组 & 干预措施

Type 2 diabetic patients with foot wounds

干预措施: questionnaire (Other)

结局指标

主要结局

Score of the Bortner self-questionnaire

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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