Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study

Recruiting

• Conditions: Foot Wound; Type 2 Diabetes
• Interventions: Other: Bortner self-questionnaire; Other: Self-questionnaire BFI-10

• Registration Number: NCT06630182
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Foot wounds in patients with diabetes are one of the most frequent complications associated with diabetes. Despite the progress made in its management in recent years, the risk of amputation remains high in cases of diabetic foot wounds.

Several studies have highlighted the value of analyzing the psychological profile A or B, defined by self-questionnaire using Bortner's method. The A personality profile is characterized by hyperactivity, combativeness and exaggerated ambition, while the B profile is characterized by less sensitivity to stress and reduced combativeness.

Type A personality profile is associated with reduced cardiovascular mortality in type 1 diabetes. Type B personality profiles have also been shown to be associated with inflammation in both type 1 and type 2 diabetes.

Our group showed that patients with diabetes and a foot wound were more likely to have a type B psychological profile than patients with diabetes and no foot wound.

However, to our knowledge, it has never been determined whether the psychosomatic profile type A or B assessed by the Bortner self-questionnaire influenced wound healing and the risk of amputation.

The aim of this study is to determine whether type A or B psychosomatic profile influences wound healing in diabetic feet.

This study will be carried out in the endocrinology, diabetology and nutrition department of the Dijon Bourgogne University Hospital. 308 patients will be included in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-11
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Person who has given his non-opposition
• Person over 18 years of age
• Person with type 2 diabetes
• Person referred for management of a new diabetic foot wound

Exclusion Criteria

• Person subject to a legal protection measure (curatorship, guardianship)
• Person subject to a legal protection measure
• Pregnant women, women in labour or breastfeeding mothers
• An adult who is incapable or unable to give consent
• Minors
• Person unable to complete self-questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetic patients with foot wounds	Bortner self-questionnaire	Patients with type 2 diabetes referred for management of a new diabetic foot wound
Type 2 diabetic patients with foot wounds	Self-questionnaire BFI-10	Patients with type 2 diabetes referred for management of a new diabetic foot wound

Primary Outcome Measures

Name	Time	Method
Bortner self-questionnaire score	At 6 months	Comparison of the Bortner self-questionnaire score in subjects with a healed diabetic foot wound and those with an unhealed foot wound.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France