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Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Universitaire de Nīmes
NCT05491577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and caregivers. The clinical signs are non-specific and it is therefore largely underestimated due to a delay in diagnosis/lack of diagnosis.This study will be on a prospective multicenter cohort of patients with chronic Charcot's foot in France to evaluate the evolution of quality of life at 2 years, as well as predictive factors in order to better identify subjects with the worst outcome among this population. Our hypothesis is that, in patients with chronic Charcot foot, the deterioration in quality of life over time is primarily related to loss of foot and ankle functionality, foot and ankle deformity and the presence of foot wounds/comorbidities/severe diabetic com

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📋 Eligibility rules (as published)
Inclusion Criteria: * patients with Type 1 or 2 diabetes or secondary diabetes * patient hospitalized or consulting for osteoarthropathy in its chronic stage, without wounds * patients affiliated to or beneficiaries of a health insurance scheme. * adult patients (≥18 years old). Exclusion Criteria: * patients with non-diabetic osteoarthropathy of the nerves. * patients with acute diabetic osteoarthropathy of the nerves. * patients with a foot ulcer * patients who have expressed opposition to participating in the study. * patients in an exclusion period determined by another study. * patients under court protection, guardianship or trusteeship. * patients for whom it is impossible to give informed information. * pregnant, parturient, or breastfeeding patients.
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What it tests

  • Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
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Where

17 sites
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, France
Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine
Bron, France
CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault
Corbeil-Essonnes, France
CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins
Grenoble, France
Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur
Le Creusot, France
CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc
Le Kremlin-Bicêtre, France
CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,
Lens, France
CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski
Lille, France

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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