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NCT Number: NCT06630182

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

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.

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Key information

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Benjamin BOUILLET

CONTACT

[email protected]

0380293453

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bortner self-questionnaire

Other

14 items

Self-questionnaire BFI-10

Other

10 items

Primary outcomes

  1. Bortner self-questionnaire score

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin BOUILLET

CONTACT

[email protected]

0380293453

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: BORTNER PIED 2

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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