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

Type 2 Diabetes Clinical Trial

— Bortner Pied  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159922
• Other study ID #: VERGES 2019
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Wound
• Type 2 Diabetes
• Wounds and Injuries

Intervention

Other:
• questionnaire
Bortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Bortner self-questionnaire		Baseline