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

NCT04159922 | Completed

• 1 other identifier: VERGES 2019
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Foot Wound

Outcome Measures

Primary Outcomes (1)

• Score of the Bortner self-questionnaire

  Baseline

Study Arms (1)

Type 2 diabetic patients with foot wounds

Other: questionnaire

Interventions

questionnaire OTHER

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

Type 2 diabetic patients with foot wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with type 2 diabetes with foot wounds

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21079, France

Location

Related Publications (1)

• Verges B, Brands R, Fourmont C, Petit JM, Simoneau I, Rouland A, Legris P, Bouillet B, Chauvet-Gelinier JC. Fewer Type A personality traits in type 2 diabetes patients with diabetic foot ulcer. Diabetes Metab. 2021 Nov;47(6):101245. doi: 10.1016/j.diabet.2021.101245. Epub 2021 Mar 12.

  PMID: 33722768 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Foot Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: December 3, 2019
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)