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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05491577
Other study ID # SI RIPH 2G : 22.01571.000083
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 23, 2023
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Sophie Schuldiner, Dr.
Phone +33 4.66.68.33.21
Email sophie.schuldiner@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and caregivers. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
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.

Locations

Country Name City State
France Centre Hospitalier de Boulogne-sur-Mer Boulogne-sur-Mer Pas-de-Calais
France Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine Bron
France CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault Corbeil-Essonnes
France CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins Grenoble
France Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur Le Creusot
France CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc Le Kremlin-Bicêtre
France CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée, Lens
France CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski Lille
France CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille Marseille
France CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud Montpellier Cedex
France GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand Paris
France GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital Paris
France Hôpital Cochin Service de diabétologie 123 Bd de Port Royal Paris
France CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet Pierre-Bénite
France CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig Reims
France Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital, Strasbourg
France Hôpital DRON Service de diabétologie 135 rue du Président Coty Tourcoing

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Sex of patients MALE/FEMALE Day 0
Other Age of patients In years Day 0
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other Patient's professional activity The patient's professional activity (if any) will be recorded Day 0
Other Patient's professional activity The patient's professional activity (if any) will be recorded Month 12
Other Patient's professional activity The patient's professional activity (if any) will be recorded Month 24
Other Nature of diabetes The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other). Day 0
Other Nature of diabetes The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other). Month 12
Other Nature of diabetes The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other). Month 24
Other 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
Other 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
Other 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
Other Presence of other complications: Retinopathy YES/NO Day 0
Other Presence of other complications: Retinopathy YES/NO Month 12
Other Presence of other complications: Retinopathy YES/NO Month 24
Other Presence of other complications: decreased visual acuity YES/NO Day 0
Other Presence of other complications: decreased visual acuity YES/NO Month 12
Other Presence of other complications: decreased visual acuity YES/NO Month 24
Other Presence of other complications: Nephropathy YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure) Day 0
Other Presence of other complications: Nephropathy YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure) Month 12
Other Presence of other complications: Nephropathy YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure) Month 24
Other 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
Other 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
Other 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
Other Presence of other complications: dialysis YES/NO Day 0
Other Presence of other complications: dialysis YES/NO Month 12
Other Presence of other complications: dialysis YES/NO Month 24
Other Presence of other complications: peripheral neuropathy YES/NO and the nature thereof: monofilament (normal, pathological, not done) Day 0
Other Presence of other complications: peripheral neuropathy YES/NO and the nature thereof: monofilament (normal, pathological, not done) Month 12
Other Presence of other complications: peripheral neuropathy YES/NO and the nature thereof: monofilament (normal, pathological, not done) Month 24
Other Presence of other complications: vegetative neuropathy YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension) Day 0
Other Presence of other complications: vegetative neuropathy YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension) Month 12
Other Presence of other complications: vegetative neuropathy YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension) Month 24
Other Presence of other complications: coronaropathy YES/NO Day 0
Other Presence of other complications: coronaropathy YES/NO Month 12
Other Presence of other complications: coronaropathy YES/NO Month 24
Other Presence of other complications: heart failure YES/NO Day 0
Other Presence of other complications: heart failure YES/NO Month 12
Other Presence of other complications: heart failure YES/NO Month 24
Other Presence of other complications: arteriopathy of the lower limbs YES/NO and the nature thereof (revascularised or not/left or right side) Day 0
Other Presence of other complications: arteriopathy of the lower limbs YES/NO and the nature thereof (revascularised or not/left or right side) Month 12
Other Presence of other complications: arteriopathy of the lower limbs YES/NO and the nature thereof (revascularised or not/left or right side) Month 24
Other Presence of other complications: involvement of the supra-aortic trunk YES/NO Day 0
Other Presence of other complications: involvement of the supra-aortic trunk YES/NO Month 12
Other Presence of other complications: involvement of the supra-aortic trunk YES/NO Month 24
Other Presence of other complications: stroke YES/NO Day 0
Other Presence of other complications: stroke YES/NO Month 12
Other Presence of other complications: stroke YES/NO Month 24
Other Presence of other complications: sequellar hemiplegia YES/NO Day 0
Other Presence of other complications: sequellar hemiplegia YES/NO Month 12
Other Presence of other complications: sequellar hemiplegia YES/NO Month 24
Other Treatments: oral antidiabetics The nature of all oral antidiabetics will be recorded. Day 0
Other Treatments: oral antidiabetics The nature of all oral antidiabetics will be recorded. Month 12
Other Treatments: oral antidiabetics The nature of all oral antidiabetics will be recorded. Month 24
Other Treatments: injectable antidiabetics The nature of all injectable antidiabetics will be recorded. Day 0
Other Treatments: injectable antidiabetics The nature of all injectable antidiabetics will be recorded. Month 12
Other Treatments: injectable antidiabetics The nature of all injectable antidiabetics will be recorded. Month 24
Other Other treatments The nature of all other treatments will be recorded. Day 0
Other Other treatments The nature of all other treatments will be recorded. Month 12
Other Other treatments The nature of all other treatments will be recorded. Month 24
Other History of trophic disorders YES/NO and, if so, left/right, both feet. Day 0
Other History of trophic disorders YES/NO and, if so, left/right, both feet. Month 12
Other History of trophic disorders YES/NO and, if so, left/right, both feet. Month 24
Other Regular pedicure treatments The number and frequency of pedicure sessions per year will be recorded (if any). Day 0
Other Regular pedicure treatments The number and frequency of pedicure sessions per year will be recorded (if any). Month 12
Other Regular pedicure treatments YES/NO and, if so, number and frequency of pedicure sessions per year will be recorded (if any). Month 24
Other Weight Kilos Day 0
Other Weight Kilos Month 12
Other Weight Kilos Month 24
Other Height Centimeters Day 0
Other Height Centimeters Month 12
Other Height Centimeters Month 24
Other Charcot foot Left/right/both Day 0
Other Charcot foot Left/right/both Month 12
Other Charcot foot Left/right/both Month 24
Other Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy In years Day 0
Other Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy In years Month 12
Other Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy In years Month 24
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other Adherence to shoeing method At home/outdoors Day 0
Other Adherence to shoeing method At home/outdoors Month 12
Other Adherence to shoeing method At home/outdoors Month 24
Other Presence of another trophic foot disorder during the previous year YES/NO and date of onset of the ulcer (month and year) Day 0
Other Presence of another trophic foot disorder during the previous year YES/NO and date of onset of the ulcer (month and year) Month 12
Other Presence of another trophic foot disorder during the previous year YES/NO and date of onset of the ulcer (month and year) Month 24
Other Presence of a clinical infection YES/NO and, if so, the Infectious Diseases Society of America classification Day 0
Other Presence of a clinical infection YES/NO and, if so, the Infectious Diseases Society of America classification Month 12
Other Presence of a clinical infection YES/NO and, if so, the Infectious Diseases Society of America classification Month 24
Other Foot or leg surgery in the previous year YES/NO and, if so, left/right Day 0
Other Foot or leg surgery in the previous year YES/NO and, if so, left/right Month 12
Other Foot or leg surgery in the previous year YES/NO and, if so, left/right Month 24
Other Partial foot amputation YES/NO and, if so, left/right Day 0
Other Partial foot amputation YES/NO and, if so, left/right Month 12
Other Partial foot amputation YES/NO and, if so, left/right Month 24
Other Trans-tibial amputation YES/NO and, if so, left/right Day 0
Other Trans-tibial amputation YES/NO and, if so, left/right Month 12
Other Trans-tibial amputation YES/NO and, if so, left/right Month 24
Other Trans-femoral amputation YES/NO and, if so, left/right Day 0
Other Trans-femoral amputation YES/NO and, if so, left/right Month 12
Other Trans-femoral amputation YES/NO and, if so, left/right Month 24
Other 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 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 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
Other Hospitalization in the previous year YES/NO and, if so, the reason why Day 0
Other Hospitalization in the previous year YES/NO and, if so, the reason why Month 12
Other Hospitalization in the previous year YES/NO and, if so, the reason why Month 24
Other Onset and management of a foot wound (medical or surgical) YES/NO and dates Day 0
Other Onset and management of a foot wound (medical or surgical) YES/NO and dates Month 12
Other Onset and management of a foot wound (medical or surgical) YES/NO and dates Month 24
Other Management of a Charcot foot YES/NO Day 0
Other Management of a Charcot foot YES/NO Month 12
Other Management of a Charcot foot YES/NO Month 24
Other Onset of a controlateral Charcot foot YES/NO Day 0
Other Onset of a controlateral Charcot foot YES/NO Month 12
Other Onset of a controlateral Charcot foot YES/NO Month 24
Other Diabetic imbalance YES/NO Day 0
Other Diabetic imbalance YES/NO Month 12
Other Diabetic imbalance YES/NO Month 24
Other Other comorbidity or other reason for surgery YES/NO Day 0
Other Other comorbidity or other reason for surgery YES/NO Month 12
Other Other comorbidity or other reason for surgery YES/NO Month 24
Other Monitoring of glycemic control by HbA1c HbA1c will be measured as a percentage Day 0
Other Monitoring of glycemic control by HbA1c HbA1c will be measured as a percentage Month 12
Other Monitoring of glycemic control by HbA1c HbA1c will be measured as a percentage Month 24
Other Monitoring of glomerular Filtration Rate ml/mn Day 0
Other Monitoring of glomerular Filtration Rate ml/mn Month 12
Other Monitoring of glomerular Filtration Rate ml/mn Month 24
Other X-ray of Charcot foot under loading (profile view) Measurement of the Djian Annonier angle and the Meary-Tomeno line Day 0
Other X-ray of Charcot foot under loading (profile view) Measurement of the Djian Annonier angle and the Meary-Tomeno line Month 12
Other X-ray of Charcot foot under loading (profile view) Measurement of the Djian Annonier angle and the Meary-Tomeno line Month 24
Other Front view X-ray of the ankle(s) under loading With Meary cerclage (metal cerclage of the hindfoot) Day 0
Other Front view X-ray of the ankle(s) under loading With Meary cerclage (metal cerclage of the hindfoot) Month 12
Other Front view X-ray of the ankle(s) under loading With Meary cerclage (metal cerclage of the hindfoot) Month 24
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy. YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy. YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy. YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy. YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy. YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy. YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease YES/NO Month 24
Secondary 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
Secondary 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
Secondary 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
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension Pressure over 140/90mmHg : YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension Pressure over 140/90mmHg : YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension Pressure over 140/90mmHg : YES/NO Month 24
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking Does the patient smoke : YES/NO Day 0
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking Does the patient smoke : YES/NO Month 12
Secondary B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking Does the patient smoke : YES/NO Month 24
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary C. Medical and/or surgical treatment for Charcot foot. All medical and/or surgical treatment for Charcot foot will be recorded. Day 0
Secondary C. Medical and/or surgical treatment for Charcot foot. All medical and/or surgical treatment for Charcot foot will be recorded. Month 12
Secondary C. Medical and/or surgical treatment for Charcot foot. All medical and/or surgical treatment for Charcot foot will be recorded. Month 24
Secondary D. Incidence of hospitalization The number of hospitalizations (if any) will be noted. Month 12
Secondary D. Incidence of hospitalization The number of hospitalizations (if any) will be noted. Month 24
Secondary E. Presence of a wound/wounds YES/NO and number thereof. Month 12
Secondary E. Presence of a wound/wounds YES/NO and number thereof. Month 24
Secondary E. Presence of an infection YES/NO Month 12
Secondary E. Presence of an infection YES/NO Month 24
Secondary F. Presence of an amputation at inclusion YES/NO (or, if planned, time to amputation in days). Day 0
Secondary G. Estimated incidence of amputations YES/NO (or, if planned, time to amputation in days). Month 12
Secondary G. Presence of an amputation YES/NO (or, if planned, time to amputation in days). Month 24
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary J. Mortality rate Vital status (dead/alive) Month 12
Secondary J. Mortality rate Vital status (dead/alive) Month 24
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03174366 - Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy Phase 3
Completed NCT05797259 - RANKL Antibody for Acute Charcot Neuro-osteoarthropathy Phase 4
Completed NCT04668755 - Effect of CROW 3d Printed Sole on Charcot Foot Ulcer N/A