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Clinical Trials/NCT06630182
NCT06630182
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country308 target enrollmentSeptember 11, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
308
Locations
1
Primary Endpoint
Bortner self-questionnaire score
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2024
End Date
September 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Person unable to complete self-questionnaires

Outcomes

Primary Outcomes

Bortner self-questionnaire score

Time Frame: 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.

Study Sites (1)

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