- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323281
Neuropsychiatric Factors (Diapepsy)
Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ariane SULTAN, PR
- Phone Number: 33 467338402
- Email: a-sultan@chu-montpellier.fr
Study Contact Backup
- Name: Sylvain ARTERO, PhD
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- Uhmontpellier
-
Contact:
- Ariane SULTAN, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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)
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring memory
Time Frame: 1 day
|
The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring memory
Time Frame: 2 years after the hospitalization
|
The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure
|
2 years after the hospitalization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of cognition by the Mini Mental State Examination (MMSE)
Time Frame: 1 day
|
Measures of cognition by the realization of Mini Mental State Examination (MMSE)
|
1 day
|
Weschler Cognition Measures
Time Frame: 1 day
|
Weschler Cognition Measurements This test will be performed over 1 day during hospitalization
|
1 day
|
Measurement of cognition by the EMPAN direct and indirect
Time Frame: 1 day
|
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)
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 2 years after the hospitalization
|
Measurement of cognition by the phonemic verbal fluence
|
2 years after the hospitalization
|
Measurement of cognition by the semantic verbal fluence
Time Frame: 2 years after the hospitalization
|
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)
Time Frame: 2 years after the hospitalization
|
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
Time Frame: 2 years after the hospitalization
|
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
Time Frame: 2 years after the hospitalization
|
Weschler Cognition Measurements
|
2 years after the hospitalization
|
Measurement of cognition by the Mini Mental State Examination (MMSE)
Time Frame: 2 years after the hospitalization
|
Measures of cognition by the realization of Mini Mental State Examination (MMSE)
|
2 years after the hospitalization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ariane SULTAN, PR, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF9805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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