Clinical Trial

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

Study acronym: BORTNER PIED 2
Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-09 -> 2028-09 2026-07-25
minor Completion pushed: 2027-09 -> 2028-09 2026-07-25
Trial Details
NCT Number NCT06630182
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Type 2 Diabetes, Foot Wound
Enrollment 308 participants
Start Date 2024-09-11
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-24