Neuropsychiatric Factors

NCT03323281 | Unknown

• 1 other identifier: UF9805
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetic foot; Cognitive functions; Psychiatric disorders; Neurology; Psychiatry

Outcome Measures

Primary Outcomes (1)

• Measuring memory

  The test of Rappel libre/Rappel indicé à 16 items (RL/RI 16) : memory measure * Range : min :0 max:16 * better or worse outcome according the population studied (age, education) (no cut off scores)

  1 day

Secondary Outcomes (1)

• Measuring memory

  2 years after the hospitalization

Other Outcomes (12)

• Measurement of cognition by the Mini Mental State Examination (MMSE)

  1 day

• Weschler Cognition Measures

  1 day

• Measurement of cognition by the EMPAN direct and indirect

  1 day

Study Arms (2)

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

Other: 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

Other: Neuropsychological assessments

Interventions

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)

Diabetic Type 1 or Type 2 with foot wound; Diabetic Type 1 or Type 2 without a foot wound or antecedent

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

133 diabetic subjects with foot wounds and 133 diabetic subjects without foot wounds

You may qualify if:

• "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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Mental Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Ariane SULTAN, PR

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Ariane SULTAN, PR

CONTACT

467338402; a-sultan@chu-montpellier.fr

Sylvain ARTERO, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: October 26, 2017
• Study Start: December 7, 2019
• Primary Completion: December 7, 2024
• Study Completion: June 7, 2025
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

FR (1)