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Recruiting Observational

Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing.

NCT06630182 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-09-11
Last updated
2026-07-24

Condition(s) studied

Type 2 DiabetesFoot Wound

Investigational drug(s) / intervention(s)

Bortner self-questionnaireSelf-questionnaire BFI-10

Bortner self-questionnaire: 14 items

Self-questionnaire BFI-10: 10 items

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. The Bortner questionnaire consists of 14 bipolar items represented graphically as a 24-point visual analog scale; the patient marks with a cross where they place themselves between the two extreme positions on the scaled line. It is completed individually without any specific time limit. Thus, for each of the 14 items, the score ranges from 0 to 24. A score of 0 corresponds to a pure Type B, while a score of 24 corresponds to a pure Type A. For items 1, 3, 4, 6, 8, 9, and 10, a score of 0 is on the right; for the other items, a score of 24 is on the right. The total score is obtained by summing the subscores corresponding to each item. The higher the score, the more the patient's behavioral profile tends toward Type A. The theoretical maximum score is therefore 336 (24 multiplied by 14 items).

Trial sites (1)

FacilityCityRegionStatus
CHU Dijon Bourgogne Dijon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06630182 on ClinicalTrials.gov ↗ ← All trials in France