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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Charcot Joint of Foot; Osteoarthropathy

Treatments: Other: Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05491577

SI RIPH 2G : 22.01571.000083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.