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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire | Other | 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sex of patients | MALE/FEMALE | Day 0 |
| Age of patients | In years | Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Schuldiner, Dr. | Contact | +33 4.66.68.33.21 | sophie.schuldiner@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33 4.66.68.42.36 | drc@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Boulogne-sur-Mer | Not yet recruiting | Boulogne-sur-Mer | Pas-de-Calais | 62200 | France |
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| 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 |
| 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:
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:
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:
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 |
| 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)
| 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)
| 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)
| 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 |
| Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine | Not yet recruiting | Bron | 69500 | France |
|
| CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault | Not yet recruiting | Corbeil-Essonnes | 91100 | France |
|
| CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins | Not yet recruiting | Grenoble | 38043 | France |
|
| Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur | Not yet recruiting | Le Creusot | 71200 | France |
|
| CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
|
| CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée, | Recruiting | Lens | 62307 | France |
|
| CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski | Not yet recruiting | Lille | 59037 | France |
|
| CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille | Not yet recruiting | Marseille | 13005 | France |
|
| CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud | Recruiting | Montpellier | 34295 | France |
|
| GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital | Recruiting | Paris | 750013 | France |
|
| GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand | Recruiting | Paris | 75014 | France |
|
| Hôpital Cochin Service de diabétologie 123 Bd de Port Royal | Not yet recruiting | Paris | 75014 | France |
|
| CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet | Recruiting | Pierre-Bénite | 69495 | France |
|
| CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig | Recruiting | Reims | 51092 | France |
|
| Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital, | Not yet recruiting | Strasbourg | 61091 | France |
|
| Hôpital DRON Service de diabétologie 135 rue du Président Coty | Recruiting | Tourcoing | 52208 | France |
|
| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003929 | Diabetic Neuropathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided