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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06630182
Acronym
BORTNER PIED 2
Enrollment
308
Registered
2024-10-08
Start date
2024-09-11
Completion date
2028-09-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Wound, Type 2 Diabetes

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.

Interventions

OTHERBortner self-questionnaire

14 items

OTHERSelf-questionnaire BFI-10

10 items

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Bortner self-questionnaire scoreAt 6 monthsComparison 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).

Countries

France

Contacts

CONTACTBenjamin BOUILLET
benjamin.bouillet@chu-dijon.fr0380293453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026