Diabetic Foot Neuroarthropathy CharcotEPiCharNCT03744039
Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers
An observational study of Diabetic Foot Neuroarthropathy Charcot, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Neuroarthropathy Charcot
- How many people
- 1,160 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2019to 24 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- The patient participates in another interventional study
- The patient refuses to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240
Nimes University Hospital
Nîmes, 30029
About this study
Official title: 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.
- Conditions
- Diabetic Foot Neuroarthropathy Charcot
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: inclusion visit
Secondary outcomes (3)
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).
Measured: 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.
Measured: inclusion visit
Register of Charcot foot
participation to a register of Charcot foot : yes/no
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Jan 2019
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Neuroarthropathy CharcotStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744039
- Sponsor's protocol ID
- 30RC18_0078
- Other IDs
- 2018-A01721-54
- Acronym
- EPiChar
- Status last verified
- Aug 2021
- First submitted
- 9 Nov 2018
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36215101
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.
- ClinicalTrials.gov ID
- NCT03744039
- Acronym / sponsor ID
- EPiChar / 30RC18_0078
- Conditions
- Diabetic Foot Neuroarthropathy Charcot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- The patient participates in another interventional study
- The patient refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Charcot foot's diagnostic criteria
Time frame: 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
Description Charcot foot's treatment
Time frame: inclusion visit
Discharge used in acute phase and/or in case of wound : yes/no Shoes used in chronic phase : yes/no
3 secondary outcomes
Number of Charcot foot
Time frame: inclusion visit
Surgery of Charcot foot
Time frame: inclusion visit
Register of Charcot foot
Time frame: inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 36215101Dardari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Neuroarthropathy Charcot, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Charcot foot's diagnostic criteria (time frame: inclusion visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.