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

NCT06630182 | Recruiting

• 1 other identifier: BOUILLET 2024
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Foot Wound

Outcome Measures

Primary Outcomes (1)

• Bortner self-questionnaire score

  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).

  At 6 months

Study Arms (1)

Type 2 diabetic patients with foot wounds

Patients with type 2 diabetes referred for management of a new diabetic foot wound

Other: Bortner self-questionnaire; Other: Self-questionnaire BFI-10

Interventions

Bortner self-questionnaire OTHER

14 items

Type 2 diabetic patients with foot wounds

Self-questionnaire BFI-10 OTHER

10 items

Type 2 diabetic patients with foot wounds

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes referred for management of a new diabetic foot ulcer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Foot Injuries

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Leg Injuries; Wounds and Injuries

Central Study Contacts

Benjamin BOUILLET

CONTACT

0380293453; benjamin.bouillet@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

FR (1)