Type 2 DiabetesBORTNER PIED 2NCT06630182
Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing.
An observational study of Type 2 Diabetes and Foot Wound, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Type 2 Diabetes, Foot Wound
- What is being tested?
- Bortner self-questionnaire and Self-questionnaire BFI-10
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2024to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with type 2 diabetes referred for management of a new diabetic foot ulcer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Benjamin BOUILLET, 0380293453, benjamin.bouillet@chu-dijon.fr
About this study
Official title: Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study
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.
Read more
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
- Being tested
- Bortner self-questionnaire, Self-questionnaire BFI-10
- Medical subject headings
- Diabetes Mellitus, Type 2, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortner self-questionnaireOther
14 items
Self-questionnaire BFI-10Other
10 items
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients with foot wounds | Patients with type 2 diabetes referred for management of a new diabetic foot wound Receives: Other: Bortner self-questionnaire; Other: Self-questionnaire BFI-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start11 Sep 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630182
- Sponsor's protocol ID
- BOUILLET 2024
- Acronym
- BORTNER PIED 2
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study
- ClinicalTrials.gov ID
- NCT06630182
- Acronym / sponsor ID
- BORTNER PIED 2 / BOUILLET 2024
- Conditions
- Type 2 Diabetes, Foot Wound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients with foot wounds | – | Other: Bortner self-questionnaire, Other: Self-questionnaire BFI-10Patients with type 2 diabetes referred for management of a new diabetic foot wound |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with type 2 diabetes referred for management of a new diabetic foot ulcer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortner self-questionnaire14 items | Other | Type 2 diabetic patients with foot wounds |
| Self-questionnaire BFI-1010 items | Other | Type 2 diabetic patients with foot wounds |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Foot Wound, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUILLET (0380293453, benjamin.bouillet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bortner self-questionnaire score (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.