Clinical trial NCT03323281: Neuropsychiatric Factors
Official title: Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Keywords: Diabetic foot
Cognitive functions
Psychiatric disorders
Neurology
Psychiatry
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-10-26
Enrollment: 266
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 133 diabetic subjects with foot wounds and 133 diabetic subjects without foot wounds

Brief summary: It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their period. The appearance of a trophic disorder in a diabetic patient is a serious complication, indicating that diabetes is often complicated. The consequences are serious for the patient with an impairment of his quality of life, but also for society with a high cost in terms of health care costs.

It should also be noted that diabetes remains the main cause of non-traumatic amputation in most developed countries, with amputation often preceded by a trophic disorder. In addition, 20% of amputees are re-amputated at least once a year. Thus, the consequences of diabetic foot injuries are important in human, social and health terms and are the subject of increased health care spending.

Many studies have shown that diabetes is a risk factor for dementia, whether it is Alzheimer's disease, Alzheimer's disease or the vascular component or pure vascular dementia.

However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the risk of the foot (evaluated by the podological risk) Specific implication of some Cognitive abilities, especially in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major impact in diabetes follow-up, therapeutic adherence and the risk of developing recurrent trophic disorders.

Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.

In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the appearance of foot wounds.

Detailed description: It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their. The occurrence of a trophic disorder in a diabetic patient is a serious complication, indicating a diabetes often complicated. The consequences are severe for the patient with an alteration of his quality of life, but also for society with a high cost in terms of healthcare costs.

It should also be pointed out that diabetes is still the leading cause of non-traumatic amputation in most developped countries, with amputation often preceded by a trophic disorder. Further, 20% of amputees are re-amputed at least once a year. Thus the consequences of the wounds of the diabetic foot are important on the human, social and health level and are the subject of an increase of the health expenses.

Many studies have shown that diabetes is a risk factor for dementia whether it is Alzheimer's disease, Alzheimer's disease with vascular component or pure vascular dementia.

However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the foot risk (evaluated by the podological risk ) and the specific involvement of certain cognitive abilities, in particular in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major implication in the follow-up of diabetes, in the therapeutic adherence and in the risk of developing recurrent trophic disorders.

Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.

In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the occurrence of foot wounds.

Eligibility 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

Primary outcomes:
measure: Measuring memory
timeFrame: 1 day
Secondary outcomes:
measure: Measuring memory
timeFrame: 2 years after the hospitalization
Other outcomes:
measure: Measurement of cognition by the Mini Mental State Examination (MMSE)
timeFrame: 1 day
measure: Weschler Cognition Measures
timeFrame: 1 day
measure: Measurement of cognition by the EMPAN direct and indirect
timeFrame: 1 day
measure: Measurement of cognition by the Trail Making A (TMTA) and Trail Making B (TMTB)
timeFrame: 1 day
measure: Measurement of cognition by the phonemic verbal fluence
timeFrame: 1 day
measure: Measurement of cognition by the semantic verbal fluence
timeFrame: 1 day
measure: Measurement of cognition by the phonemic verbal fluence
timeFrame: 2 years after the hospitalization
measure: Measurement of cognition by the semantic verbal fluence
timeFrame: 2 years after the hospitalization
measure: Measurement of cognition by the the Trail Making A (TMTA) and Trail Making B (TMTB)
timeFrame: 2 years after the hospitalization
measure: Measurement of cognition by the empan direct and indirect
timeFrame: 2 years after the hospitalization
measure: Weschler Cognition Measures
timeFrame: 2 years after the hospitalization
measure: Measurement of cognition by the Mini Mental State Examination (MMSE)
timeFrame: 2 years after the hospitalization
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Ariane SULTAN, PR
role: STUDY_DIRECTOR
References: