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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Neuroarthropathy Charcot

• Study Type: Observational
• Enrollment (Actual): 1160

Contacts and Locations

Study Locations

• France
  • Le Grau-du-Roi, France, 30240
    • CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
  • Nîmes, France, 30029
    • Nimes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

290-1160 consecutive patients with type 1 or type 2 diabetes mellitus and acute or chronic osteo-neuroarthropathy in 29 diabetic-foot centers in France and Belgium (members of workgroup " diabetic foot " in French-speaking Society of Diabetology)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Register of Charcot foot	participation to a register of Charcot foot : yes/no	inclusion visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Dardari D, Schuldiner S, Julien CA, Ha Van G, M'Bemba J, Bourgeon M, Sultan A, Lepeut M, Grandperret-Vauthier S, Baudoux F, Francois M, Clavel S, Martini J, Vouillarmet J, Michon P, Moret M, Monnier A, Chingan-Martino V, Rigalleau V, Dumont I, Kessler L, Stifii I, Bouillet B, Bonnin P, Lemoine A, Da Costa Correia E, Faraill MMB, Muller M, Cazaubiel M, Zemmache MZ, Hartemann A. Trends in the relation between hyperglycemia correction and active Charcot neuroarthropathy: results from the EPICHAR study. BMJ Open Diabetes Res Care. 2022 Sep;10(5):e002380. doi: 10.1136/bmjdrc-2021-002380.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 24, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 30RC18_0078; 2018-A01721-54 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No