Charcot Joint of FootCHARQUAMNCT05491577
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
An observational study of Charcot Joint of Foot and Osteoarthropathy, run by Centre Hospitalier Universitaire de Nīmes at 17 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Charcot Joint of Foot, Osteoarthropathy
- What is being tested?
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- How many people
- 150 participants
- Where
- 17 sitesFrance
- Study dates
- 23 Jan 2023to 22 Jan 2028
- Phase
- Observational
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: The source population corresponds to all diabetic patients (Type 1, 2 or secondary diabetes) hospitalized or consulting for chronic diabetic osteoarthropathy of the nerves, without wound managed in the participating centers.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, Pas-de-Calais, 62200
Marie Lepage, Dr, +33 3 21 99 30 34, m.lepage@ch-boulogne.fr
- Not yet recruiting
Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine
Bron, 69500
Myriam MORET, Dr
- Not yet recruiting
CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault
Corbeil-Essonnes, 91100
Dured DARDARI, Dr.
- Not yet recruiting
CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins
Grenoble, 38043
Marie Muller, Dr.
- Not yet recruiting
Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur
Le Creusot, 71200
Haleh MOHEBBI, Dr.
- Recruiting
CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc
Le Kremlin-Bicêtre, 94275
Muriel BOURGEON, Dr
- Recruiting
CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,
Lens, 62307
Fabrice DEVEMY, Dr
- Not yet recruiting
CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski
Lille, 59037
Florence BAUDOUX, Dr.
- Not yet recruiting
CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille
Marseille, 13005
Rachel GRANGEOT-PATTE, Dr.
- Recruiting
CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud
Montpellier, 34295
Ariane SULTAN, Pr
- Recruiting
GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital
Paris, 750013
Georges HA VAN, Dr.
- Recruiting
GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand
Paris, 75014
Olivier DUPUY, Dr.
Camille BAUDRY, Dr.
- Not yet recruiting
Hôpital Cochin Service de diabétologie 123 Bd de Port Royal
Paris, 75014
Jocelyne MBEMBA, Dr
- Recruiting
CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet
Pierre-Bénite, 69495
Julien VOUILLARMET, Dr.
- Recruiting
CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig
Reims, 51092
Maud FRANCOIS, Dr.
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital,
Strasbourg, 61091
Laurence KESSLER, Dr.
- Recruiting
Hôpital DRON Service de diabétologie 135 rue du Président Coty
Tourcoing, 52208
Marie CAZAUBIEL, Dr.
About this study
Official title: Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
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.
Read the detailed 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.
- Conditions
- Charcot Joint of Foot, Osteoarthropathy
- Being tested
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- Keywords
- Diabetes complications, Diabetic foot, Osteoarthropathy
- Medical subject headings
- Diabetes Complications, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaireOther
The SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire will all be filled in by the patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the SF36 questionnaire at inclusion
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Measured: Day 0
Results of the FAAM-F questionnaire at inclusion
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Measured: Day 0
Results of the SF36 questionnaire at Month 12
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Measured: Month 12
Results of the FAAM-F questionnaire at Month 12
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Measured: Month 12
Results of the SF36 questionnaire at Month 24
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Measured: Month 24
Results of the FAAM-F questionnaire at Month 24
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Measured: Month 24
Secondary outcomes (75)
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
In normal metatarsal alignment, the lateral border of the 1st metatarsal is aligned with lateral border of 1st (medial) cuneiform. The medial border of 2nd metatarsal is aligned with the medial border of 2nd (intermediate) cuneiform.The medial border of the 3rd (lateral) cuneiform should align with the medial border of the 3rd metatarsal. The lateral border of the 3rd (lateral) cuneiform should align with the lateral border of the 3rd metatarsal. The medial border of the 4th metatarsal is aligned with the medial border of the cuboid. The lateral margin of the 5th metatarsal can project lateral to cuboid by up to 3 mm on oblique. This alignment is known as the Méary Line and is assessed in front view.
Measured: Day 0
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
In normal metatarsal alignment, the lateral border of the 1st metatarsal is aligned with lateral border of 1st (medial) cuneiform. The medial border of 2nd metatarsal is aligned with the medial border of 2nd (intermediate) cuneiform.The medial border of the 3rd (lateral) cuneiform should align with the medial border of the 3rd metatarsal. The lateral border of the 3rd (lateral) cuneiform should align with the lateral border of the 3rd metatarsal. The medial border of the 4th metatarsal is aligned with the medial border of the cuboid. The lateral margin of the 5th metatarsal can project lateral to cuboid by up to 3 mm on oblique. This alignment is known as the Méary Line and is assessed in front view.
Measured: Month 12
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
In normal metatarsal alignment, the lateral border of the 1st metatarsal is aligned with lateral border of 1st (medial) cuneiform. The medial border of 2nd metatarsal is aligned with the medial border of 2nd (intermediate) cuneiform.The medial border of the 3rd (lateral) cuneiform should align with the medial border of the 3rd metatarsal. The lateral border of the 3rd (lateral) cuneiform should align with the lateral border of the 3rd metatarsal. The medial border of the 4th metatarsal is aligned with the medial border of the cuboid. The lateral margin of the 5th metatarsal can project lateral to cuboid by up to 3 mm on oblique. This alignment is known as the Méary Line and is assessed in front view.
Measured: Month 24
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.
Meary's angle (the angle between the line from the center of the talus body, intersecting the neck and head of the talus, and the line through the longitudinal axis of the 1st metatarsal) will be measured in profile view, in degrees. The normal value is about 0°.
Measured: Day 0
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.
Meary's angle (the angle between the line from the center of the talus body, intersecting the neck and head of the talus, and the line through the longitudinal axis of the 1st metatarsal) will be measured in profile view, in degrees. The normal value is about 0°.
Measured: Month 12
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.
Meary's angle (the angle between the line from the center of the talus body, intersecting the neck and head of the talus, and the line through the longitudinal axis of the 1st metatarsal) will be measured in profile view, in degrees. The normal value is about 0°.
Measured: Month 24
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope
The calcaneal slope angle (line tangent to the inferior cortex of the calcaneus (angle between this line and a horizontal line) will be measured in degrees. Normal values are10-30° on the profile X-ray.
Measured: Day 0
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope
The calcaneal slope angle (line tangent to the inferior cortex of the calcaneus (angle between this line and a horizontal line) will be measured in degrees. Normal values are10-30° on the profile X-ray.
Measured: Month 12
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope
The calcaneal slope angle (line tangent to the inferior cortex of the calcaneus (angle between this line and a horizontal line) will be measured in degrees. Normal values are10-30° on the profile X-ray.
Measured: Month 24
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle
The Djian-Annonier angle will be measured (line between lower point of the talo-navicular joint and lower point of the medial sesamoid bone at the hallux). Line tangent to the inferior surface of the calcaneus. Normal value: 120-130° on profile X-ray.
Measured: Day 0
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle
The Djian-Annonier angle will be measured (line between lower point of the talo-navicular joint and lower point of the medial sesamoid bone at the hallux). Line tangent to the inferior surface of the calcaneus. Normal value: 120-130° on profile X-ray.
Measured: Month 12
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle
The Djian-Annonier angle will be measured (line between lower point of the talo-navicular joint and lower point of the medial sesamoid bone at the hallux). Line tangent to the inferior surface of the calcaneus. Normal value: 120-130° on profile X-ray.
Measured: Month 24
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment
The rearfoot alignment angle i.e. angle between the axis of the tibia and the line between the middle of the plantar support plane and the middle of talus will be measured in degrees..
Measured: Day 0
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment
The rearfoot alignment angle i.e. angle between the axis of the tibia and the line between the middle of the plantar support plane and the middle of talus will be measured in degrees..
Measured: Month 12
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment
The rearfoot alignment angle i.e. angle between the axis of the tibia and the line between the middle of the plantar support plane and the middle of talus will be measured in degrees..
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes
YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes
YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes
YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension
Pressure over 140/90mmHg : YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension
Pressure over 140/90mmHg : YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension
Pressure over 140/90mmHg : YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking
Does the patient smoke : YES/NO
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking
Does the patient smoke : YES/NO
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking
Does the patient smoke : YES/NO
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Measured: Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index
The Charlson comorbidity index predicts the 1-year mortality for patient with a range of comorbid conditions, e.g. heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Clinical conditions and associated scores are as follows:
- each: Myocardial infarct, congestive heart failure, peripheral vascular disease, dementia, cerebrovascular disease, chronic lung disease, connective tissue disease, ulcer, chronic liver disease, diabetes.
- each: Hemiplegia, moderate or severe kidney disease, diabetes with end organ damage, tumor, leukemia, lymphoma.
- each: Moderate or severe liver disease.
6 each: Malignant tumor, metastasis, AIDS.
Measured: Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index
The Charlson comorbidity index predicts the 1-year mortality for patient with a range of comorbid conditions, e.g. heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Clinical conditions and associated scores are as follows:
- each: Myocardial infarct, congestive heart failure, peripheral vascular disease, dementia, cerebrovascular disease, chronic lung disease, connective tissue disease, ulcer, chronic liver disease, diabetes.
- each: Hemiplegia, moderate or severe kidney disease, diabetes with end organ damage, tumor, leukemia, lymphoma.
- each: Moderate or severe liver disease.
6 each: Malignant tumor, metastasis, AIDS.
Measured: Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index
The Charlson comorbidity index predicts the 1-year mortality for patient with a range of comorbid conditions, e.g. heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Clinical conditions and associated scores are as follows:
- each: Myocardial infarct, congestive heart failure, peripheral vascular disease, dementia, cerebrovascular disease, chronic lung disease, connective tissue disease, ulcer, chronic liver disease, diabetes.
- each: Hemiplegia, moderate or severe kidney disease, diabetes with end organ damage, tumor, leukemia, lymphoma.
- each: Moderate or severe liver disease.
6 each: Malignant tumor, metastasis, AIDS.
Measured: Month 24
C. Medical and/or surgical treatment for Charcot foot.
All medical and/or surgical treatment for Charcot foot will be recorded.
Measured: Day 0
C. Medical and/or surgical treatment for Charcot foot.
All medical and/or surgical treatment for Charcot foot will be recorded.
Measured: Month 12
C. Medical and/or surgical treatment for Charcot foot.
All medical and/or surgical treatment for Charcot foot will be recorded.
Measured: Month 24
D. Incidence of hospitalization
The number of hospitalizations (if any) will be noted.
Measured: Month 12
D. Incidence of hospitalization
The number of hospitalizations (if any) will be noted.
Measured: Month 24
E. Presence of a wound/wounds
YES/NO and number thereof.
Measured: Month 12
E. Presence of a wound/wounds
YES/NO and number thereof.
Measured: Month 24
E. Presence of an infection
YES/NO
Measured: Month 12
E. Presence of an infection
YES/NO
Measured: Month 24
F. Presence of an amputation at inclusion
YES/NO (or, if planned, time to amputation in days).
Measured: Day 0
G. Estimated incidence of amputations
YES/NO (or, if planned, time to amputation in days).
Measured: Month 12
G. Presence of an amputation
YES/NO (or, if planned, time to amputation in days).
Measured: Month 24
H. Precarity of patients with chronic Charcot foot.
The EPICES (Evaluation de la précarité et des inégalités de santé dans les Centres d'examens) score is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. The main interest of the EPICES score is to capture populations which, while not covered by traditional administrative indicators of precariousness present the same health risks. A threshold of 30 is considered as precariousness according to EPICES.
Measured: Day 0
H. Precarity of patients with chronic Charcot foot.
The EPICES (Evaluation de la précarité et des inégalités de santé dans les Centres d'examens) score is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. The main interest of the EPICES score is to capture populations which, while not covered by traditional administrative indicators of precariousness present the same health risks. A threshold of 30 is considered as precariousness according to EPICES.
Measured: Month 12
H. Precarity of patients with chronic Charcot foot.
The EPICES (Evaluation de la précarité et des inégalités de santé dans les Centres d'examens) score is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. The main interest of the EPICES score is to capture populations which, while not covered by traditional administrative indicators of precariousness present the same health risks. A threshold of 30 is considered as precariousness according to EPICES.
Measured: Month 24
I. Depression according to the PHQ-2 self-questionnaire
The purpose of the PHQ-2 is to screen for depression in a "first-step" approach. there are 2 questions referring to the patient's feelings over the previous 2 weeks ( 0 = Not at all and 3 = Nearly every day). A PHQ-2 score ranges from 0-6 and a score of 3 is the optimal cutoff point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely and the PHQ-9 questionnaire should then be used.
Measured: Day 0
I. Depression according to the PHQ-2 self-questionnaire
The purpose of the PHQ-2 is to screen for depression in a "first-step" approach. there are 2 questions referring to the patient's feelings over the previous 2 weeks ( 0 = Not at all and 3 = Nearly every day). A PHQ-2 score ranges from 0-6 and a score of 3 is the optimal cutoff point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely and the PHQ-9 questionnaire should then be used.
Measured: Month 24
I. Depression according to the PHQ-2 self-questionnaire
The purpose of the PHQ-2 is to screen for depression in a "first-step" approach. there are 2 questions referring to the patient's feelings over the previous 2 weeks ( 0 = Not at all and 3 = Nearly every day). A PHQ-2 score ranges from 0-6 and a score of 3 is the optimal cutoff point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely and the PHQ-9 questionnaire should then be used.
Measured: Month 12
I. Depression according to the PHQ-9 self-questionnaire
The PHQ-9 questionnaire is a set of 9 questions referring to the patients feelings over the previous 2 weeks with answers ranging from 0 = Not at all to 3 = Nearly every day. Interpreted as follows : 1-4 = minimum depression ; 5-9 = slight depression;10-14 = moderate depression;15-19 = moderately severe depression and 20-27 = severe depression.
Measured: Day 0
I. Depression according to the PHQ-9 self-questionnaire
The PHQ-9 questionnaire is a set of 9 questions referring to the patients feelings over the previous 2 weeks with answers ranging from 0 = Not at all to 3 = Nearly every day. Interpreted as follows : 1-4 = minimum depression ; 5-9 = slight depression;10-14 = moderate depression;15-19 = moderately severe depression and 20-27 = severe depression.
Measured: Month 12
I. Depression according to the PHQ-9 self-questionnaire
The PHQ-9 questionnaire is a set of 9 questions referring to the patients feelings over the previous 2 weeks with answers ranging from 0 = Not at all to 3 = Nearly every day. Interpreted as follows : 1-4 = minimum depression ; 5-9 = slight depression;10-14 = moderate depression;15-19 = moderately severe depression and 20-27 = severe depression.
Measured: Month 24
J. Mortality rate
Vital status (dead/alive)
Measured: Month 12
J. Mortality rate
Vital status (dead/alive)
Measured: Month 24
K. Sanders Classification of the Charcot Foot
The Sanders classification will be used to assess the degree of damage to the patient's foot as follows :
Sanders I = Metatarsophalangeal involvement (forefoot) Sanders II= Tarsometatarsal joint involvement Sanders III= Tarsal joints involvement Sanders IV= Ankle involvement Sanders V= Posterior calcaneus involvement (tuberosity of the calcaneus, avulsion of the Achilles tendon)
and all information will be recorded for the evaluation of the patient's quality of life.
Measured: Day 0
K. Sanders Classification of the Charcot Foot
The Sanders classification will be used to assess the degree of damage to the patient's foot as follows :
Sanders I = Metatarsophalangeal involvement (forefoot) Sanders II= Tarsometatarsal joint involvement Sanders III= Tarsal joints involvement Sanders IV= Ankle involvement Sanders V= Posterior calcaneus involvement (tuberosity of the calcaneus, avulsion of the Achilles tendon)
and all information will be recorded for the evaluation of the patient's quality of life.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start23 Jan 2023
- Primary completion22 Jul 2027 (estimated)
- Study completion22 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot Joint of FootStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
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
- NCT05491577
- Sponsor's protocol ID
- SI RIPH 2G : 22.01571.000083
- Acronym
- CHARQUAM
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2022
- Last updated
- 23 Oct 2026
- Results posted
- No