Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire.
- Who it may be relevant to
- Registry conditions: Charcot Joint of Foot, Osteoarthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Results of the SF36 questionnaire at inclusion [Time frame: Day 0]
- Results of the FAAM-F questionnaire at inclusion [Time frame: Day 0]
- Results of the SF36 questionnaire at Month 12 [Time frame: Month 12]
- Results of the FAAM-F questionnaire at Month 12 [Time frame: Month 12]
- Results of the SF36 questionnaire at Month 24 [Time frame: Month 24]
- Results of the FAAM-F questionnaire at Month 24 [Time frame: Month 24]
Secondary outcome measures (12)
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Time frame: Day 0]
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Time frame: Month 12]
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) [Time frame: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Time frame: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Time frame: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. [Time frame: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Time frame: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Time frame: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope [Time frame: Month 24]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Time frame: Day 0]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Time frame: Month 12]
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle [Time frame: Month 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 17 centers
- 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
- … and 9 more centers
Identifiers
NCT: NCT05491577 · SI RIPH 2G : 22.01571.000083