Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire.
- Кому может быть актуально
- Состояния в реестре: Charcot Joint of Foot, Osteoarthropathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
Обзор
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 complications.
Подробное описание
Diabetes mellitus is a chronic disease, representing a major public health problem. An estimated 537 million people have diabetes. Charcot foot, also known as neurogenic osteoarthropathy (NAO), is one of the complications of diabetes secondary to diabetic neuropathy. It is characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot. Charcot foot is a complication of diabetes that is still poorly understood by patients and caregivers, with non-specific clinical signs. It is therefore largely underestimated, since it is estimated that there is a delay in diagnosis or a lack of diagnosis in approximately 25% of cases.
The objective of our study is to conduct a prospective multicenter cohort of patients with chronic Charcot's foot in France in order to evaluate the evolution of the quality of life at 2 years, as well as its predictive factors. In this way, we will be better able to identify the subjects with the worst outcome among the chronic Charcot foot population.
Our hypothesis is that the deterioration in quality of life over time in patients with chronic Charcot foot is primarily related to loss of foot and ankle functionality, foot and ankle deformity, the presence of foot wounds and/or comorbidities or severe diabetic complications.
Вмешательства
- Другое Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
The SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire will all be filled in by the patients.
Первичные конечные точки
- Results of the SF36 questionnaire at inclusion [Срок оценки: Day 0]
- Results of the FAAM-F questionnaire at inclusion [Срок оценки: Day 0]
- Results of the SF36 questionnaire at Month 12 [Срок оценки: Month 12]
- Results of the FAAM-F questionnaire at Month 12 [Срок оценки: Month 12]
- Results of the SF36 questionnaire at Month 24 [Срок оценки: Month 24]
- Results of the FAAM-F questionnaire at Month 24 [Срок оценки: Month 24]
Вторичные конечные точки (12)
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Срок оценки: Day 0]
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Срок оценки: Month 12]
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Срок оценки: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Срок оценки: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Срок оценки: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Срок оценки: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Срок оценки: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Срок оценки: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Срок оценки: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Срок оценки: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Срок оценки: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Срок оценки: Month 24]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 17 центров
- Centre Hospitalier de Boulogne-sur-Mer — Boulogne-sur-Mer
- Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen L — Bron
- CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault — Corbeil-Essonnes
- CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins — Grenoble
- Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur — Le Creusot
- CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Lecl — Le Kremlin-Bicêtre
- CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr S — Lens
- CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, — Lille
- … и ещё 9 центров
Идентификаторы
NCT: NCT05491577 · SI RIPH 2G : 22.01571.000083