Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
- Conditions
- Charcot Joint of FootOsteoarthropathy
- Registration Number
- NCT05491577
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief 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.
- Detailed Description
Diabetes mellitus is a chronic disease, representing a major public health problem. An estimated 537 million people have diabetes. Charcot foot, also known as neurogenic osteoarthropathy (NAO), is one of the complications of diabetes secondary to diabetic neuropathy. It is characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot. Charcot foot is a complication of diabetes that is still poorly understood by patients and caregivers, with non-specific clinical signs. It is therefore largely underestimated, since it is estimated that there is a delay in diagnosis or a lack of diagnosis in approximately 25% of cases.
The objective of our study is to conduct a prospective multicenter cohort of patients with chronic Charcot's foot in France in order to evaluate the evolution of the quality of life at 2 years, as well as its predictive factors. In this way, we will be better able to identify the subjects with the worst outcome among the chronic Charcot foot population.
Our hypothesis is that the deterioration in quality of life over time in patients with chronic Charcot foot is primarily related to loss of foot and ankle functionality, foot and ankle deformity, the presence of foot wounds and/or comorbidities or severe diabetic complications.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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).
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Results of the SF36 questionnaire at inclusion 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.
Results of the SF36 questionnaire at Month 12 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.
Results of the SF36 questionnaire at Month 24 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.
Results of the FAAM-F questionnaire at inclusion 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.
Results of the FAAM-F questionnaire at Month 12 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.
Results of the FAAM-F questionnaire at Month 24 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.
- Secondary Outcome Measures
Name Time Method B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy Month 12 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy. Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure Month 24 YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line) 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.
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle. 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°.
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope 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.
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle 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.
A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment 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..
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking Month 24 Does the patient smoke : YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status Month 24 Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score
C. Medical and/or surgical treatment for Charcot foot. Month 24 All medical and/or surgical treatment for Charcot foot will be recorded.
D. Incidence of hospitalization Month 24 The number of hospitalizations (if any) will be noted.
F. Presence of an amputation at inclusion Day 0 YES/NO (or, if planned, time to amputation in days).
I. Depression according to the PHQ-2 self-questionnaire 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.
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy. Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index 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:
1. each: Myocardial infarct, congestive heart failure, peripheral vascular disease, dementia, cerebrovascular disease, chronic lung disease, connective tissue disease, ulcer, chronic liver disease, diabetes.
2. each: Hemiplegia, moderate or severe kidney disease, diabetes with end organ damage, tumor, leukemia, lymphoma.
3. each: Moderate or severe liver disease.
6 each: Malignant tumor, metastasis, AIDS.E. Presence of a wound/wounds Month 24 YES/NO and number thereof.
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease Month 24 YES/NO
B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension Month 24 Pressure over 140/90mmHg : YES/NO
E. Presence of an infection Month 24 YES/NO
G. Estimated incidence of amputations Month 12 YES/NO (or, if planned, time to amputation in days).
G. Presence of an amputation Month 24 YES/NO (or, if planned, time to amputation in days).
H. Precarity of patients with chronic Charcot foot. 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.
I. Depression according to the PHQ-9 self-questionnaire 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.
J. Mortality rate Month 24 Vital status (dead/alive)
K. Sanders Classification of the Charcot Foot 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.
Trial Locations
- Locations (17)
Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine
🇫🇷Bron, France
CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig
🇫🇷Reims, France
GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital
🇫🇷Paris, France
GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand
🇫🇷Paris, France
Hôpital DRON Service de diabétologie 135 rue du Président Coty
🇫🇷Tourcoing, France
Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur
🇫🇷Le Creusot, France
CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud
🇫🇷Montpellier Cedex, France
Hôpital Cochin Service de diabétologie 123 Bd de Port Royal
🇫🇷Paris, France
CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault
🇫🇷Corbeil-Essonnes, France
CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,
🇫🇷Lens, 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 de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins
🇫🇷Grenoble, France
CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc
🇫🇷Le Kremlin-Bicêtre, France
CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille
🇫🇷Marseille, France
CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski
🇫🇷Lille, France
Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital,
🇫🇷Strasbourg, France
Centre Hospitalier de Boulogne-sur-Mer
🇫🇷Boulogne-sur-Mer, Pas-de-Calais, France