Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot (CHARQUAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Charcot Joint of Foot; Osteoarthropathy
• Intervention / Treatment: Other: Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: +33 4.66.68.42.36; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Sophie Schuldiner, Dr.; Phone Number: +33 4.66.68.33.21; Email: sophie.schuldiner@chu-nimes.fr

Study Locations

• France
  • Bron, France, 69500
    • Not yet recruiting
    • Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine
    • Contact: Myriam MORET, Dr
  • Corbeil-Essonnes, France, 91100
    • Not yet recruiting
    • CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault
    • Contact: Dured DARDARI, Dr.
  • Grenoble, France, 38043
    • Not yet recruiting
    • CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins
    • Contact: Marie Muller, Dr.
  • Le Creusot, France, 71200
    • Not yet recruiting
    • Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur
    • Contact: Haleh MOHEBBI, Dr.
  • Le Kremlin-Bicêtre, France, 94275
    • Recruiting
    • CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc
    • Contact: Muriel BOURGEON, Dr
  • Lens, France, 62307
    • Recruiting
    • CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,
    • Contact: Fabrice DEVEMY, Dr
  • Lille, France, 59037
    • Not yet recruiting
    • CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski
    • Contact: Florence BAUDOUX, Dr.
  • Marseille, France, 13005
    • Not yet recruiting
    • CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille
    • Contact: Rachel GRANGEOT-PATTE, Dr.
  • Montpellier Cedex, France, 34295
    • Recruiting
    • CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud
    • Contact: Ariane SULTAN, Pr
  • Paris, France, 750013
    • Recruiting
    • GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital
    • Contact: Georges HA VAN, Dr.
  • Paris, France, 75014
    • Recruiting
    • GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand
    • Contact: Olivier DUPUY, Dr.
    • Sub-Investigator: Camille BAUDRY, Dr.
    • Sub-Investigator: Lucile JOLIE, Dr.
    • Principal Investigator: Florence BOUILLOUD-CHATILLON, Dr.
  • Paris, France, 75014
    • Not yet recruiting
    • Hôpital Cochin Service de diabétologie 123 Bd de Port Royal
    • Contact: Jocelyne MBEMBA, Dr
  • Pierre-Bénite, France, 69495
    • Recruiting
    • CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet
    • Contact: Julien VOUILLARMET, Dr.
  • Reims, France, 51092
    • Recruiting
    • CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig
    • Contact: Maud FRANCOIS, Dr.
  • Strasbourg, France, 61091
    • Not yet recruiting
    • Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital,
    • Contact: Laurence KESSLER, Dr.
  • Tourcoing, France, 52208
    • Recruiting
    • Hôpital DRON Service de diabétologie 135 rue du Président Coty
    • Contact: Marie CAZAUBIEL, Dr.
  • Pas-de-Calais
    • Boulogne-sur-Mer, Pas-de-Calais, France, 62200
      • Not yet recruiting
      • Centre Hospitalier de Boulogne-sur-mer
      • Contact: Marie Lepage, Dr; Phone Number: +33 3 21 99 30 34; Email: m.lepage@ch-boulogne.fr

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

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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

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
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.	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.	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.	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.	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.	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.	Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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°.	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°.	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°.	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.	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.	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.	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.	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.	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.	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..	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..	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..	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease	YES/NO	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%)	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%)	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%)	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes	YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes	YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes	YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension	Pressure over 140/90mmHg : YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension	Pressure over 140/90mmHg : YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension	Pressure over 140/90mmHg : YES/NO	Month 24
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking	Does the patient smoke : YES/NO	Day 0
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking	Does the patient smoke : YES/NO	Month 12
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking	Does the patient smoke : YES/NO	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	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	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	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.	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.	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.	Month 24
C. Medical and/or surgical treatment for Charcot foot.	All medical and/or surgical treatment for Charcot foot will be recorded.	Day 0
C. Medical and/or surgical treatment for Charcot foot.	All medical and/or surgical treatment for Charcot foot will be recorded.	Month 12
C. Medical and/or surgical treatment for Charcot foot.	All medical and/or surgical treatment for Charcot foot will be recorded.	Month 24
D. Incidence of hospitalization	The number of hospitalizations (if any) will be noted.	Month 12
D. Incidence of hospitalization	The number of hospitalizations (if any) will be noted.	Month 24
E. Presence of a wound/wounds	YES/NO and number thereof.	Month 12
E. Presence of a wound/wounds	YES/NO and number thereof.	Month 24
E. Presence of an infection	YES/NO	Month 12
E. Presence of an infection	YES/NO	Month 24
F. Presence of an amputation at inclusion	YES/NO (or, if planned, time to amputation in days).	Day 0
G. Estimated incidence of amputations	YES/NO (or, if planned, time to amputation in days).	Month 12
G. Presence of an amputation	YES/NO (or, if planned, time to amputation in days).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Month 24
J. Mortality rate	Vital status (dead/alive)	Month 12
J. Mortality rate	Vital status (dead/alive)	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.	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.	Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex of patients	MALE/FEMALE	Day 0
Age of patients	In years	Day 0
Patient's personal situation	Lives alone/ Lives with family or has family nearby/Primary caregiver of another person/Lives in a bungalow/ Lives in a 2 or 3-storey house/ No fixed abode / Visits from a state-registered nurse/ Home help / Physiotherapy	Day 0
Patient's personal situation	Lives alone/ Lives with family or has family nearby/Primary caregiver of another person/Lives in a bungalow/ Lives in a 2 or 3-storey house/ No fixed abode / Visits from a state-registered nurse/ Home help / Physiotherapy	Month 12
Patient's personal situation	Lives alone/ Lives with family or has family nearby/Primary caregiver of another person/Lives in a bungalow/ Lives in a 2 or 3-storey house/ No fixed abode / Visits from a state-registered nurse/ Home help / Physiotherapy	Month 24
Patient's level of education	The patient's level of education will be recorded: No diploma (including: no schooling or schooling completed before the end of elementary school; schooling completed until the end of elementary school or completed before the end of junior high school; schooling until the end of junior high school or beyond); Primary school certificate;; BEPC, brevet élémentaire, brevet des collèges, DNB ;; CAP, BEP or equivalent diploma;; Baccalaureate, vocational diploma including: general or technological baccalaureate, higher diploma, capacity in law, DAEU, ESEU; vocational baccalaureate, vocational, technician or teaching diploma, equivalent diploma;; BTS, DUT, DEUG, DEUST, health or social diploma of Bac+2 level, equivalent diploma;; Bachelor's degree, professional license, master's degree, equivalent diploma of bac+3 or bac+4 level;; Master's degree, DEA, DESS, diploma from an engineering school at Bac+5 level, health doctorate;; Research doctorate (not in health).	Day 0
Patient's level of education	The patient's level of education will be recorded: No diploma (including: no schooling or schooling completed before the end of elementary school; schooling completed until the end of elementary school or completed before the end of junior high school; schooling until the end of junior high school or beyond); Primary school certificate;; BEPC, brevet élémentaire, brevet des collèges, DNB ;; CAP, BEP or equivalent diploma;; Baccalaureate, vocational diploma including: general or technological baccalaureate, higher diploma, capacity in law, DAEU, ESEU; vocational baccalaureate, vocational, technician or teaching diploma, equivalent diploma;; BTS, DUT, DEUG, DEUST, health or social diploma of Bac+2 level, equivalent diploma;; Bachelor's degree, professional license, master's degree, equivalent diploma of bac+3 or bac+4 level;; Master's degree, DEA, DESS, diploma from an engineering school at Bac+5 level, health doctorate;; Research doctorate (not in health).	Month 12
Patient's level of education	The patient's level of education will be recorded: No diploma (including: no schooling or schooling completed before the end of elementary school; schooling completed until the end of elementary school or completed before the end of junior high school; schooling until the end of junior high school or beyond); Primary school certificate;; BEPC, brevet élémentaire, brevet des collèges, DNB ;; CAP, BEP or equivalent diploma;; Baccalaureate, vocational diploma including: general or technological baccalaureate, higher diploma, capacity in law, DAEU, ESEU; vocational baccalaureate, vocational, technician or teaching diploma, equivalent diploma;; BTS, DUT, DEUG, DEUST, health or social diploma of Bac+2 level, equivalent diploma;; Bachelor's degree, professional license, master's degree, equivalent diploma of bac+3 or bac+4 level;; Master's degree, DEA, DESS, diploma from an engineering school at Bac+5 level, health doctorate;; Research doctorate (not in health).	Month 24
Patient's professional activity	The patient's professional activity (if any) will be recorded	Day 0
Patient's professional activity	The patient's professional activity (if any) will be recorded	Month 12
Patient's professional activity	The patient's professional activity (if any) will be recorded	Month 24
Nature of diabetes	The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).	Day 0
Nature of diabetes	The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).	Month 12
Nature of diabetes	The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).	Month 24
Age of diabetes	The age of the patient's diabetes will be recorded (More than 20 years/ 10 to 20 years/ 5 to 10 years/ less than 5 years/ unknown).	Day 0
Age of diabetes	The age of the patient's diabetes will be recorded (More than 20 years/ 10 to 20 years/ 5 to 10 years/ less than 5 years/ unknown).	Month 12
Age of diabetes	The age of the patient's diabetes will be recorded (More than 20 years/ 10 to 20 years/ 5 to 10 years/ less than 5 years/ unknown).	Month 24
Presence of other complications: Retinopathy	YES/NO	Day 0
Presence of other complications: Retinopathy	YES/NO	Month 12
Presence of other complications: Retinopathy	YES/NO	Month 24
Presence of other complications: decreased visual acuity	YES/NO	Day 0
Presence of other complications: decreased visual acuity	YES/NO	Month 12
Presence of other complications: decreased visual acuity	YES/NO	Month 24
Presence of other complications: Nephropathy	YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)	Day 0
Presence of other complications: Nephropathy	YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)	Month 12
Presence of other complications: Nephropathy	YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)	Month 24
Presence of other complications: Abnormal glomerular filtration rate (GFR)	GFR between 60 and 89ml/min/1.73 m² / GFR between 15 and 29ml/min/1.73 m² / GFR < 15 ml/min/1.73 m²	Day 0
Presence of other complications: Abnormal glomerular filtration rate (GFR)	GFR between 60 and 89ml/min/1.73 m² / GFR between 15 and 29ml/min/1.73 m² / GFR < 15 ml/min/1.73 m²	Month 12
Presence of other complications: Abnormal glomerular filtration rate (GFR)	GFR between 60 and 89ml/min/1.73 m² / GFR between 15 and 29ml/min/1.73 m² / GFR < 15 ml/min/1.73 m²	Month 24
Presence of other complications: dialysis	YES/NO	Day 0
Presence of other complications: dialysis	YES/NO	Month 12
Presence of other complications: dialysis	YES/NO	Month 24
Presence of other complications: peripheral neuropathy	YES/NO and the nature thereof: monofilament (normal, pathological, not done)	Day 0
Presence of other complications: peripheral neuropathy	YES/NO and the nature thereof: monofilament (normal, pathological, not done)	Month 12
Presence of other complications: peripheral neuropathy	YES/NO and the nature thereof: monofilament (normal, pathological, not done)	Month 24
Presence of other complications: vegetative neuropathy	YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)	Day 0
Presence of other complications: vegetative neuropathy	YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)	Month 12
Presence of other complications: vegetative neuropathy	YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)	Month 24
Presence of other complications: coronaropathy	YES/NO	Day 0
Presence of other complications: coronaropathy	YES/NO	Month 12
Presence of other complications: coronaropathy	YES/NO	Month 24
Presence of other complications: heart failure	YES/NO	Day 0
Presence of other complications: heart failure	YES/NO	Month 12
Presence of other complications: heart failure	YES/NO	Month 24
Presence of other complications: arteriopathy of the lower limbs	YES/NO and the nature thereof (revascularised or not/left or right side)	Day 0
Presence of other complications: arteriopathy of the lower limbs	YES/NO and the nature thereof (revascularised or not/left or right side)	Month 12
Presence of other complications: arteriopathy of the lower limbs	YES/NO and the nature thereof (revascularised or not/left or right side)	Month 24
Presence of other complications: involvement of the supra-aortic trunk	YES/NO	Day 0
Presence of other complications: involvement of the supra-aortic trunk	YES/NO	Month 12
Presence of other complications: involvement of the supra-aortic trunk	YES/NO	Month 24
Presence of other complications: stroke	YES/NO	Day 0
Presence of other complications: stroke	YES/NO	Month 12
Presence of other complications: stroke	YES/NO	Month 24
Presence of other complications: sequellar hemiplegia	YES/NO	Day 0
Presence of other complications: sequellar hemiplegia	YES/NO	Month 12
Presence of other complications: sequellar hemiplegia	YES/NO	Month 24
Treatments: oral antidiabetics	The nature of all oral antidiabetics will be recorded.	Day 0
Treatments: oral antidiabetics	The nature of all oral antidiabetics will be recorded.	Month 12
Treatments: oral antidiabetics	The nature of all oral antidiabetics will be recorded.	Month 24
Treatments: injectable antidiabetics	The nature of all injectable antidiabetics will be recorded.	Day 0
Treatments: injectable antidiabetics	The nature of all injectable antidiabetics will be recorded.	Month 12
Treatments: injectable antidiabetics	The nature of all injectable antidiabetics will be recorded.	Month 24
Other treatments	The nature of all other treatments will be recorded.	Day 0
Other treatments	The nature of all other treatments will be recorded.	Month 12
Other treatments	The nature of all other treatments will be recorded.	Month 24
History of trophic disorders	YES/NO and, if so, left/right, both feet.	Day 0
History of trophic disorders	YES/NO and, if so, left/right, both feet.	Month 12
History of trophic disorders	YES/NO and, if so, left/right, both feet.	Month 24
Regular pedicure treatments	The number and frequency of pedicure sessions per year will be recorded (if any).	Day 0
Regular pedicure treatments	The number and frequency of pedicure sessions per year will be recorded (if any).	Month 12
Regular pedicure treatments	YES/NO and, if so, number and frequency of pedicure sessions per year will be recorded (if any).	Month 24
Weight	Kilos	Day 0
Weight	Kilos	Month 12
Weight	Kilos	Month 24
Height	Centimeters	Day 0
Height	Centimeters	Month 12
Height	Centimeters	Month 24
Charcot foot	Left/right/both	Day 0
Charcot foot	Left/right/both	Month 12
Charcot foot	Left/right/both	Month 24
Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy	In years	Day 0
Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy	In years	Month 12
Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy	In years	Month 24
Neurogenic osteoarthropathy Sanders classification	Sanders 1: interphalangeal and metatarsophalangeal joints Sanders 2: tarsometatarsal joints Sanders 3 : naviculocuneiform, talonavicular or calcaneocuboid joints Sanders 4 : ankle joint, subtalar joint Sanders 5: calcaneum	Day 0
Neurogenic osteoarthropathy Sanders classification	Sanders 1: interphalangeal and metatarsophalangeal joints Sanders 2: tarsometatarsal joints Sanders 3 : naviculocuneiform, talonavicular or calcaneocuboid joints Sanders 4 : ankle joint, subtalar joint Sanders 5: calcaneum	Month 12
Neurogenic osteoarthropathy Sanders classification	Sanders 1: interphalangeal and metatarsophalangeal joints Sanders 2: tarsometatarsal joints Sanders 3 : naviculocuneiform, talonavicular or calcaneocuboid joints Sanders 4 : ankle joint, subtalar joint Sanders 5: calcaneum	Month 24
Current mode of shoeing/unfastening at home	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Day 0
Current mode of shoeing/unfastening outdoors	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Day 0
Current mode of shoeing/unfastening at home	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Month 12
Current mode of shoeing/unfastening outdoors	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Month 12
Current mode of shoeing/unfastening at home	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Month 24
Current mode of shoeing/unfastening outdoors	Barefoot and/or socks; serial sock; serial medical sock; normal shoe; normal medical shoe; foot orthosis; orthopedic low shaft shoe; orthopedic high shaft shoe; standard off-loading shoe; custom off-loading shoe ; standard removable boot; custom removable boot; non-removable boot; other...	Month 24
Adherence to shoeing method	At home/outdoors	Day 0
Adherence to shoeing method	At home/outdoors	Month 12
Adherence to shoeing method	At home/outdoors	Month 24
Presence of another trophic foot disorder during the previous year	YES/NO and date of onset of the ulcer (month and year)	Day 0
Presence of another trophic foot disorder during the previous year	YES/NO and date of onset of the ulcer (month and year)	Month 12
Presence of another trophic foot disorder during the previous year	YES/NO and date of onset of the ulcer (month and year)	Month 24
Presence of a clinical infection	YES/NO and, if so, the Infectious Diseases Society of America classification	Day 0
Presence of a clinical infection	YES/NO and, if so, the Infectious Diseases Society of America classification	Month 12
Presence of a clinical infection	YES/NO and, if so, the Infectious Diseases Society of America classification	Month 24
Foot or leg surgery in the previous year	YES/NO and, if so, left/right	Day 0
Foot or leg surgery in the previous year	YES/NO and, if so, left/right	Month 12
Foot or leg surgery in the previous year	YES/NO and, if so, left/right	Month 24
Partial foot amputation	YES/NO and, if so, left/right	Day 0
Partial foot amputation	YES/NO and, if so, left/right	Month 12
Partial foot amputation	YES/NO and, if so, left/right	Month 24
Trans-tibial amputation	YES/NO and, if so, left/right	Day 0
Trans-tibial amputation	YES/NO and, if so, left/right	Month 12
Trans-tibial amputation	YES/NO and, if so, left/right	Month 24
Trans-femoral amputation	YES/NO and, if so, left/right	Day 0
Trans-femoral amputation	YES/NO and, if so, left/right	Month 12
Trans-femoral amputation	YES/NO and, if so, left/right	Month 24
Other type of surgery	All other types of surgery : septic surgery / correction of morphostatic disorders of the forefoot / internal and/or external fixators / bone graft / correction of club foot will be recorded.	Day 0
Other type of surgery	All other types of surgery : septic surgery / correction of morphostatic disorders of the forefoot / internal and/or external fixators / bone graft / correction of club foot will be recorded.	Month 12
Other type of surgery	All other types of surgery : septic surgery / correction of morphostatic disorders of the forefoot / internal and/or external fixators / bone graft / correction of club foot will be recorded.	Month 24
Hospitalization in the previous year	YES/NO and, if so, the reason why	Day 0
Hospitalization in the previous year	YES/NO and, if so, the reason why	Month 12
Hospitalization in the previous year	YES/NO and, if so, the reason why	Month 24
Onset and management of a foot wound (medical or surgical)	YES/NO and dates	Day 0
Onset and management of a foot wound (medical or surgical)	YES/NO and dates	Month 12
Onset and management of a foot wound (medical or surgical)	YES/NO and dates	Month 24
Management of a Charcot foot	YES/NO	Day 0
Management of a Charcot foot	YES/NO	Month 12
Management of a Charcot foot	YES/NO	Month 24
Onset of a controlateral Charcot foot	YES/NO	Day 0
Onset of a controlateral Charcot foot	YES/NO	Month 12
Onset of a controlateral Charcot foot	YES/NO	Month 24
Diabetic imbalance	YES/NO	Day 0
Diabetic imbalance	YES/NO	Month 12
Diabetic imbalance	YES/NO	Month 24
Other comorbidity or other reason for surgery	YES/NO	Day 0
Other comorbidity or other reason for surgery	YES/NO	Month 12
Other comorbidity or other reason for surgery	YES/NO	Month 24
Monitoring of glycemic control by HbA1c	HbA1c will be measured as a percentage	Day 0
Monitoring of glycemic control by HbA1c	HbA1c will be measured as a percentage	Month 12
Monitoring of glycemic control by HbA1c	HbA1c will be measured as a percentage	Month 24
Monitoring of glomerular Filtration Rate	ml/mn	Day 0
Monitoring of glomerular Filtration Rate	ml/mn	Month 12
Monitoring of glomerular Filtration Rate	ml/mn	Month 24
X-ray of Charcot foot under loading (profile view)	Measurement of the Djian Annonier angle and the Meary-Tomeno line	Day 0
X-ray of Charcot foot under loading (profile view)	Measurement of the Djian Annonier angle and the Meary-Tomeno line	Month 12
X-ray of Charcot foot under loading (profile view)	Measurement of the Djian Annonier angle and the Meary-Tomeno line	Month 24
Front view X-ray of the ankle(s) under loading	With Meary cerclage (metal cerclage of the hindfoot)	Day 0
Front view X-ray of the ankle(s) under loading	With Meary cerclage (metal cerclage of the hindfoot)	Month 12
Front view X-ray of the ankle(s) under loading	With Meary cerclage (metal cerclage of the hindfoot)	Month 24

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): January 22, 2028

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic foot; Diabetes complications; Osteoarthropathy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthropathy, Neurogenic
• Other Study ID Numbers: SI RIPH 2G : 22.01571.000083