Type 2 DiabetesBortner PiedNCT04159922
Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds
An observational study of Type 2 Diabetes and Foot Wound, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Foot Wound
- What is being tested?
- questionnaire
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2019to 18 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with type 2 diabetes with foot wounds
Who may be able to join
- diagnosis of type 2 diabetes
- patient > 18 years old
- with a diabetic foot wound
- person who has expressed non-opposiyion to participation in the study
Who cannot join
- a person who is not affiliated to national health insurance
- person subject to legal protection (curatorship, guardianship)
- person under limited judicial protection
- pregnant, parturient or breastfeeding woman
- adult unable to consent
- minor
Trial locations and contacts
1 site in 1 country.
About this study
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.
It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.
Read more
Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.
It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.
- Conditions
- Type 2 Diabetes, Foot Wound
- Being tested
- questionnaire
- 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.
questionnaireOther
Bortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients with foot wounds | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Bortner self-questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start3 Dec 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 66 participants (actual)
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
- NCT04159922
- Sponsor's protocol ID
- VERGES 2019
- Acronym
- Bortner Pied
- Status last verified
- Jan 2026
- First submitted
- 8 Nov 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verges B, Brands R, Fourmont C, Petit JM, Simoneau I, Rouland A, Legris P, Bouillet B, Chauvet-Gelinier JC. Fewer Type A personality traits in type 2 diabetes patients with diabetic foot ulcer. Diabetes Metab. 2021 Nov;47(6):101245. doi: 10.1016/j.diabet.2021.101245. Epub 2021 Mar 12.
PubMed 33722768
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds
- ClinicalTrials.gov ID
- NCT04159922
- Acronym / sponsor ID
- Bortner Pied / VERGES 2019
- Conditions
- Type 2 Diabetes, Foot Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 12 Nov 2019 (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.
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.
It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.
Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.
It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients with foot wounds | – | Other: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with type 2 diabetes with foot wounds
Key inclusion criteria (4 listed)
- diagnosis of type 2 diabetes
- patient > 18 years old
- with a diabetic foot wound
- person who has expressed non-opposiyion to participation in the study
Key exclusion criteria (6 listed)
- a person who is not affiliated to national health insurance
- person subject to legal protection (curatorship, guardianship)
- person under limited judicial protection
- pregnant, parturient or breastfeeding woman
- adult unable to consent
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 |
|---|---|---|
| questionnaireBortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items | Other | Type 2 diabetic patients with foot wounds |
Primary outcome
Score of the Bortner self-questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 33722768Verges B, Brands R, Fourmont C, Petit JM, Simoneau I, Rouland A, Legris P, Bouillet B, Chauvet-Gelinier JC. Fewer Type A personality traits in type 2 diabetes patients with diabetic foot ulcer. Diabetes Metab. 2021 Nov;47(6):101245. doi: 10.1016/j.diabet.2021.101245. Epub 2021 Mar 12.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Bortner self-questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159922, which also lists 1 linked publication.
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 3 Feb 2026.