Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers

Diabetic Foot Neuroarthropathy Charcot Clinical Trial

— EPiChar  

Official title:

Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744039
• Other study ID #: RCB : 2018-A01721-54
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 24, 2019

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient has received written information about the study and did not oppose to participate

• The patient is affiliated to a health insurance programme

• The patient is at least 18 years old

• The patient is admitted to hospitalization or consultation

• The patient is diagnosed with type 1 or type 2 diabetes mellitus

• The patient is diagnosed with acute or chronic osteo-neuroarthropathy

Exclusion Criteria:

• The patient participates in another interventional study

• The patient refuses to participate

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Neuroarthropathy Charcot

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi	Le Grau du Roi
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Charcot foot's diagnostic criteria	triggering factors : yes/no acute symptoms : : yes/no chronic symptoms : yes/no Presence of associated soft tissue infection : yes/no Presence of an associated bone infection : yes/no examinations performed to confirm the diagnosis of Charcot : yes/no	inclusion visit
Primary	Description Charcot foot's treatment	Discharge used in acute phase and/or in case of wound : yes/no Shoes used in chronic phase : yes/no	inclusion visit
Secondary	Number of Charcot foot	To determine diabetic patients' number with acute or chronic Charcot foot cared in diabetic-foot center in France and Belgium over a year (estimation of Charcot foot's incidence in diabetic-foot centers).	inclusion visit
Secondary	Surgery of Charcot foot	To identify which diabetic-foot centers propose surgical management in Charcot foot, to describe the type of surgery and the indications of surgical treatment.	inclusion visit
Secondary	Register of Charcot foot	participation to a register of Charcot foot : yes/no	inclusion visit