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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorCentre Hospitalier Universitaire Dijon

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bortner self-questionnaire

    Other intervention

    14 items

  • Self-questionnaire BFI-10

    Other intervention

    10 items

Treatment groups

308 Participants
are divided into 1 treatment group
Group A: Type 2 diabetic patients with foot wounds2 interventions

Trial outcomes

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.

Time frame
At 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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