Understanding neuropsychiatric factors in diabetic patients with foot wounds
Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients
This study looks at how mental health and thinking skills affect people with diabetes who have foot wounds, comparing them to those without foot wounds to see how it impacts their care and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 266 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03323281 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the neuropsychiatric factors associated with diabetic patients, particularly focusing on those with foot wounds. It will assess cognitive functions and psychiatric disorders in diabetic individuals, evaluating the impact of these factors on the management and recurrence of diabetic foot complications. The study will include both diabetic patients with foot wounds and those without, allowing for a comparative analysis of cognitive abilities and decision-making skills. Neuropsychological assessments will be conducted to gather data on the participants' cognitive health.
Who should consider this trial
Good fit: Ideal candidates for this study are diabetic individuals over 45 years old, both type 1 and type 2, with or without foot wounds.
Not a fit: Patients who are unable to complete cognitive tests or self-questionnaires due to physical or sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for diabetic patients, potentially reducing the incidence of foot wounds and amputations.
How similar studies have performed: While there have been studies linking diabetes to cognitive decline, this specific approach integrating cognitive assessments with diabetic foot complications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: "Diabetic subjects with foot wounds" * Subjects over 45 years old * Diabetic type 1 or type 2 with foot wound (podological risk grade 3) in hospitalization in the Nutrition-Diabetes Unit CHU Lapeyronie or in the Department of Metabolic Diseases CHRU Grau du Roi. * Having given their informed consent for the study "Diabetic subjects without a foot wound" * Subjects over 45 years old * Type 1 or type 2 diabetics without a foot wound or previous foot wound (grade 0 to 2 grade, including Charcot foot) hospitalized or seen for consultation in the Nutrition-Diabetes Unit LaUyronie CHU or Metabolic Diseases CHRU Grau of the King. * Having given their informed consent for the study Exclusion Criteria: * Patients who can not complete the self-questionnaires or can not carry out the cognitive tests (blindness, non-French speaking patient, illiteracy) * Major physical or neurosensory problems that may interfere with the tests
Where this trial is running
Montpellier
- Uhmontpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Ariane SULTAN, PR
- Email: a-sultan@chu-montpellier.fr
- Phone: 467338402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.