NCT06630182 Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study
| NCT ID | NCT06630182 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 308 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 308 participants in total. It began in 2024-09-11 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * Minors * Person unable to complete self-questionnaires
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06630182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 18 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06630182 currently recruiting?
Yes, NCT06630182 is actively recruiting participants. Contact the research team at benjamin.bouillet@chu-dijon.fr for enrollment information.
Where is the NCT06630182 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT06630182 clinical trial?
NCT06630182 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 308 participants.
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