- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159922
Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds (Bortner Pied)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France, 21079
- Chu Dijon Bourogne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- minor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Type 2 diabetic patients with foot wounds
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Bortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Score of the Bortner self-questionnaire
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Wounds and Injuries
- Metabolic Diseases
- Leg Injuries
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Foot Injuries
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- VERGES 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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