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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Type 1 or Type 2 with foot wound | Type 1 or type 2 diabetic patients with hospitalization for foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments |
| |
| Diabetic Type 1 or Type 2 without a foot wound or antecedent | Type 1 or Type 2 diabetic patients with no foot wounds or history of foot wounds having an interview with a neuropsychologist or a physician trained in neuropsychological assessments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological assessments | Other | Maintenance of approximately 1h30 with a neuropsychologist or a physician trained in neuropsychological assessments in Diabetic Type 1 or Type 2 with foot wound hospitalization and Diabetic Type 1 or Type 2 without a foot wound or antecedent Of foot wound (podological risk grade 0 to 2, including foot of Charcot) |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring memory | The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring memory | The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
| 2 years after the hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of cognition by the Mini Mental State Examination (MMSE) | Measures of cognition by the realization of Mini Mental State Examination (MMSE)
| 1 day |
| Weschler Cognition Measures |
Inclusion Criteria:
"Diabetic subjects with foot wounds"
"Diabetic subjects without a foot wound"
Exclusion Criteria:
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133 diabetic subjects with foot wounds and 133 diabetic subjects without foot wounds
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariane SULTAN, PR | Contact | 467338402 | 33 | a-sultan@chu-montpellier.fr |
| Sylvain ARTERO, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Ariane SULTAN, PR | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uhmontpellier | Recruiting | Montpellier | 34295 | France |
NC
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
Weschler Cognition Measurements This test will be performed over 1 day during hospitalization |
| 1 day |
| Measurement of cognition by the EMPAN direct and indirect | Measurement of cognition by the EMPAN direct and indirect EMPAN direct : Range : 1-8 and no cut off score EMPAN indirect : Range : 1-8 and no cut off score This test will be performed over 1 day during hospitalization | 1 day |
| Measurement of cognition by the Trail Making A (TMTA) and Trail Making B (TMTB) | Measurement of cognition by the TMTA and TMTB Trail Making A : Range : 0-26 and no cut off score Trail Making B : Range : 0-13 and no cut off score This test will be performed over 1 day during hospitalization | 1 day |
| Measurement of cognition by the phonemic verbal fluence | Measurement of cognition by the phonemic verbal fluence This test will be performed over 1 day during hospitalization | 1 day |
| Measurement of cognition by the semantic verbal fluence | Measurement of cognition by the semantic verbal fluence This test will be performed over 1 day during hospitalization | 1 day |
| Measurement of cognition by the phonemic verbal fluence | Measurement of cognition by the phonemic verbal fluence | 2 years after the hospitalization |
| Measurement of cognition by the semantic verbal fluence | Measurement of cognition by the semantic verbal fluence | 2 years after the hospitalization |
| Measurement of cognition by the the Trail Making A (TMTA) and Trail Making B (TMTB) | Measurement of cognition by the TMTA and TMTB Trail Making A : Range : 0-26 and no cut off score Trail Making B : Range : 0-13 and no cut off score | 2 years after the hospitalization |
| Measurement of cognition by the empan direct and indirect | Measurement of cognition by the EMPAN direct and indirect EMPAN direct : Range : 1-8 and no cut off score EMPAN indirect : Range : 1-8 and no cut off score | 2 years after the hospitalization |
| Weschler Cognition Measures | Weschler Cognition Measurements | 2 years after the hospitalization |
| Measurement of cognition by the Mini Mental State Examination (MMSE) | Measures of cognition by the realization of Mini Mental State Examination (MMSE)
| 2 years after the hospitalization |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |