Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
OtherThe 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.
NCT Number: NCT05491577
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Centre Hospitalier de Boulogne-sur-Mer, Boulogne-sur-Mer, Pas-de-Calais, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
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°.
Time frame: Month 12
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°.
Time frame: Month 24
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°.
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
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..
Time frame: Month 12
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..
Time frame: Month 24
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..
Time frame: Month 24
YES/NO
Time frame: Month 12
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Time frame: Month 12
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Time frame: Month 24
YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
Pressure over 140/90mmHg : YES/NO
Time frame: Month 12
Pressure over 140/90mmHg : YES/NO
Time frame: Month 24
Pressure over 140/90mmHg : YES/NO
Time frame: Day 0
Does the patient smoke : YES/NO
Time frame: Month 12
Does the patient smoke : YES/NO
Time frame: Month 24
Does the patient smoke : YES/NO
Time frame: Day 0
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Time frame: Month 12
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Time frame: Month 24
Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
All medical and/or surgical treatment for Charcot foot will be recorded.
Time frame: Month 12
All medical and/or surgical treatment for Charcot foot will be recorded.
Time frame: Month 24
All medical and/or surgical treatment for Charcot foot will be recorded.
Time frame: Month 12
The number of hospitalizations (if any) will be noted.
Time frame: Month 24
The number of hospitalizations (if any) will be noted.
Time frame: Month 12
YES/NO and number thereof.
Time frame: Month 24
YES/NO and number thereof.
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO (or, if planned, time to amputation in days).
Time frame: Month 12
YES/NO (or, if planned, time to amputation in days).
Time frame: Month 24
YES/NO (or, if planned, time to amputation in days).
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
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.
Time frame: Month 24
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.
Time frame: Month 12
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.
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Month 12
Vital status (dead/alive)
Time frame: Month 24
Vital status (dead/alive)
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Day 0
MALE/FEMALE
Time frame: Day 0
In years
Time frame: Day 0
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
Time frame: Month 12
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
Time frame: Month 24
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
Time frame: Day 0
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)
Time frame: Month 12
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)
Time frame: Month 24
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)
Time frame: Day 0
The patient's professional activity (if any) will be recorded
Time frame: Month 12
The patient's professional activity (if any) will be recorded
Time frame: Month 24
The patient's professional activity (if any) will be recorded
Time frame: Day 0
The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).
Time frame: Month 12
The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).
Time frame: Month 24
The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).
Time frame: Day 0
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).
Time frame: Month 12
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).
Time frame: Month 24
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).
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)
Time frame: Month 12
YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)
Time frame: Month 24
YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)
Time frame: Day 0
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
Time frame: Month 12
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
Time frame: Month 24
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
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO and the nature thereof: monofilament (normal, pathological, not done)
Time frame: Month 12
YES/NO and the nature thereof: monofilament (normal, pathological, not done)
Time frame: Month 24
YES/NO and the nature thereof: monofilament (normal, pathological, not done)
Time frame: Day 0
YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)
Time frame: Month 12
YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)
Time frame: Month 24
YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO and the nature thereof (revascularised or not/left or right side)
Time frame: Month 12
YES/NO and the nature thereof (revascularised or not/left or right side)
Time frame: Month 24
YES/NO and the nature thereof (revascularised or not/left or right side)
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
The nature of all oral antidiabetics will be recorded.
Time frame: Month 12
The nature of all oral antidiabetics will be recorded.
Time frame: Month 24
The nature of all oral antidiabetics will be recorded.
Time frame: Day 0
The nature of all injectable antidiabetics will be recorded.
Time frame: Month 12
The nature of all injectable antidiabetics will be recorded.
Time frame: Month 24
The nature of all injectable antidiabetics will be recorded.
Time frame: Day 0
The nature of all other treatments will be recorded.
Time frame: Month 12
The nature of all other treatments will be recorded.
Time frame: Month 24
The nature of all other treatments will be recorded.
Time frame: Day 0
YES/NO and, if so, left/right, both feet.
Time frame: Month 12
YES/NO and, if so, left/right, both feet.
Time frame: Month 24
YES/NO and, if so, left/right, both feet.
Time frame: Day 0
The number and frequency of pedicure sessions per year will be recorded (if any).
Time frame: Month 12
The number and frequency of pedicure sessions per year will be recorded (if any).
Time frame: Month 24
YES/NO and, if so, number and frequency of pedicure sessions per year will be recorded (if any).
Time frame: Day 0
Kilos
Time frame: Month 12
Kilos
Time frame: Month 24
Kilos
Time frame: Day 0
Centimeters
Time frame: Month 12
Centimeters
Time frame: Month 24
Centimeters
Time frame: Day 0
Left/right/both
Time frame: Month 12
Left/right/both
Time frame: Month 24
Left/right/both
Time frame: Day 0
In years
Time frame: Month 12
In years
Time frame: Month 24
In years
Time frame: Day 0
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
Time frame: Month 12
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
Time frame: Month 24
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
Time frame: Day 0
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...
Time frame: Day 0
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...
Time frame: Month 12
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...
Time frame: Month 12
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...
Time frame: Month 24
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...
Time frame: Month 24
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...
Time frame: Day 0
At home/outdoors
Time frame: Month 12
At home/outdoors
Time frame: Month 24
At home/outdoors
Time frame: Day 0
YES/NO and date of onset of the ulcer (month and year)
Time frame: Month 12
YES/NO and date of onset of the ulcer (month and year)
Time frame: Month 24
YES/NO and date of onset of the ulcer (month and year)
Time frame: Day 0
YES/NO and, if so, the Infectious Diseases Society of America classification
Time frame: Month 12
YES/NO and, if so, the Infectious Diseases Society of America classification
Time frame: Month 24
YES/NO and, if so, the Infectious Diseases Society of America classification
Time frame: Day 0
YES/NO and, if so, left/right
Time frame: Month 12
YES/NO and, if so, left/right
Time frame: Month 24
YES/NO and, if so, left/right
Time frame: Day 0
YES/NO and, if so, left/right
Time frame: Month 12
YES/NO and, if so, left/right
Time frame: Month 24
YES/NO and, if so, left/right
Time frame: Day 0
YES/NO and, if so, left/right
Time frame: Month 12
YES/NO and, if so, left/right
Time frame: Month 24
YES/NO and, if so, left/right
Time frame: Day 0
YES/NO and, if so, left/right
Time frame: Month 12
YES/NO and, if so, left/right
Time frame: Month 24
YES/NO and, if so, left/right
Time frame: Day 0
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.
Time frame: Month 12
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.
Time frame: Month 24
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.
Time frame: Day 0
YES/NO and, if so, the reason why
Time frame: Month 12
YES/NO and, if so, the reason why
Time frame: Month 24
YES/NO and, if so, the reason why
Time frame: Day 0
YES/NO and dates
Time frame: Month 12
YES/NO and dates
Time frame: Month 24
YES/NO and dates
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
YES/NO
Time frame: Month 12
YES/NO
Time frame: Month 24
YES/NO
Time frame: Day 0
HbA1c will be measured as a percentage
Time frame: Month 12
HbA1c will be measured as a percentage
Time frame: Month 24
HbA1c will be measured as a percentage
Time frame: Day 0
ml/mn
Time frame: Month 12
ml/mn
Time frame: Month 24
ml/mn
Time frame: Day 0
Measurement of the Djian Annonier angle and the Meary-Tomeno line
Time frame: Month 12
Measurement of the Djian Annonier angle and the Meary-Tomeno line
Time frame: Month 24
Measurement of the Djian Annonier angle and the Meary-Tomeno line
Time frame: Day 0
With Meary cerclage (metal cerclage of the hindfoot)
Time frame: Month 12
With Meary cerclage (metal cerclage of the hindfoot)
Time frame: Month 24
With Meary cerclage (metal cerclage of the hindfoot)
Contact information is provided by the study sponsor or research team.
Anissa MEGZARI
CONTACT
Sophie Schuldiner, Dr.
CONTACT
Centre Hospitalier Universitaire de Nīmes
Other
Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
Acronym: CHARQUAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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