Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing.
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 volunteersQualifiers
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 intervention14 items
Self-questionnaire BFI-10
Other intervention10 items
Treatment groups
308 Participants
are divided into 1 treatment groupGroup 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. 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).
Time frame
At 6 monthsSponsors and contacts
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Source ClinicalTrials.gov