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

Completed

• Conditions: Diabetic Foot Neuroarthropathy Charcot

• Registration Number: NCT03744039
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2019-01-01
• Primary Completion: 2019-12-24
• Study Completion: 2019-12-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description Charcot foot's treatment	inclusion visit	Discharge used in acute phase and/or in case of wound : yes/no Shoes used in chronic phase : yes/no
Charcot foot's diagnostic criteria	inclusion visit	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

Secondary Outcome Measures

Name	Time	Method
Register of Charcot foot	inclusion visit	participation to a register of Charcot foot : yes/no
Surgery of Charcot foot	inclusion visit	To identify which diabetic-foot centers propose surgical management in Charcot foot, to describe the type of surgery and the indications of surgical treatment.
Number of Charcot foot	inclusion visit	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).

Trial Locations

Locations (2)

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi; 🇫🇷 Le Grau du Roi, France

Nimes University Hospital; 🇫🇷 Nîmes, France