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NCT Number: NCT05491577

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

Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and caregivers. The clinical signs are non-specific and it is therefore largely underestimated due to a delay in diagnosis/lack of diagnosis.This study will be on a prospective multicenter cohort of patients with chronic Charcot's foot in France to evaluate the evolution of quality of life at 2 years, as well as predictive factors in order to better identify subjects with the worst outcome among this population.

Our hypothesis is that, in patients with chronic Charcot foot, the deterioration in quality of life over time is primarily related to loss of foot and ankle functionality, foot and ankle deformity and the presence of foot wounds/comorbidities/severe diabetic complications.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Boulogne-sur-Mer, Boulogne-sur-Mer, Pas-de-Calais, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

The SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire will all be filled in by the patients.

Primary outcomes

  1. Results of the SF36 questionnaire at inclusion

    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.

  2. Results of the FAAM-F questionnaire at inclusion

    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.

  3. Results of the SF36 questionnaire at Month 12

    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.

  4. Results of the FAAM-F questionnaire at Month 12

    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.

  5. Results of the SF36 questionnaire at Month 24

    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.

  6. Results of the FAAM-F questionnaire at Month 24

    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.

Secondary outcomes

  1. A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)

    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.

  2. A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)

    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.

  3. A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)

    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.

  4. A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.

    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°.

  5. A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.

    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°.

  6. A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.

    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°.

  7. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope

    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.

  8. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope

    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.

  9. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope

    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.

  10. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle

    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.

  11. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle

    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.

  12. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle

    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.

  13. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment

    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..

  14. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment

    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..

  15. A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment

    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..

  16. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy

    Time frame: Month 24

    YES/NO

  17. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy

    Time frame: Month 12

    YES/NO

  18. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.

    Time frame: Day 0

    YES/NO

  19. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.

    Time frame: Month 12

    YES/NO

  20. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.

    Time frame: Month 24

    YES/NO

  21. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.

    Time frame: Day 0

    YES/NO

  22. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.

    Time frame: Month 12

    YES/NO

  23. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.

    Time frame: Month 24

    YES/NO

  24. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy

    Time frame: Day 0

    YES/NO

  25. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy

    Time frame: Month 12

    YES/NO

  26. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy

    Time frame: Month 24

    YES/NO

  27. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement

    Time frame: Day 0

    YES/NO

  28. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement

    Time frame: Month 12

    YES/NO

  29. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement

    Time frame: Month 24

    YES/NO

  30. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease

    Time frame: Day 0

    YES/NO

  31. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease

    Time frame: Month 12

    YES/NO

  32. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease

    Time frame: Month 24

    YES/NO

  33. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure

    Time frame: Day 0

    YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)

  34. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure

    Time frame: Month 12

    YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)

  35. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure

    Time frame: Month 24

    YES/NO (measured according to a Left Ventricle Ejection Fraction of less than 50%)

  36. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes

    Time frame: Day 0

    YES/NO

  37. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes

    Time frame: Month 12

    YES/NO

  38. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes

    Time frame: Month 24

    YES/NO

  39. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension

    Time frame: Day 0

    Pressure over 140/90mmHg : YES/NO

  40. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension

    Time frame: Month 12

    Pressure over 140/90mmHg : YES/NO

  41. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension

    Time frame: Month 24

    Pressure over 140/90mmHg : YES/NO

  42. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking

    Time frame: Day 0

    Does the patient smoke : YES/NO

  43. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking

    Time frame: Month 12

    Does the patient smoke : YES/NO

  44. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking

    Time frame: Month 24

    Does the patient smoke : YES/NO

  45. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status

    Time frame: Day 0

    Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score

  46. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status

    Time frame: Month 12

    Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score

  47. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status

    Time frame: Month 24

    Does the patient drink more than 3 glasses of alcohol per day : YES/NO alcohol status Charlson score

  48. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index

    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:

    • 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.

  49. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index

    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:

    • 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.

  50. B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index

    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:

    • 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.

  51. C. Medical and/or surgical treatment for Charcot foot.

    Time frame: Day 0

    All medical and/or surgical treatment for Charcot foot will be recorded.

  52. C. Medical and/or surgical treatment for Charcot foot.

    Time frame: Month 12

    All medical and/or surgical treatment for Charcot foot will be recorded.

  53. C. Medical and/or surgical treatment for Charcot foot.

    Time frame: Month 24

    All medical and/or surgical treatment for Charcot foot will be recorded.

  54. D. Incidence of hospitalization

    Time frame: Month 12

    The number of hospitalizations (if any) will be noted.

  55. D. Incidence of hospitalization

    Time frame: Month 24

    The number of hospitalizations (if any) will be noted.

  56. E. Presence of a wound/wounds

    Time frame: Month 12

    YES/NO and number thereof.

  57. E. Presence of a wound/wounds

    Time frame: Month 24

    YES/NO and number thereof.

  58. E. Presence of an infection

    Time frame: Month 12

    YES/NO

  59. E. Presence of an infection

    Time frame: Month 24

    YES/NO

  60. F. Presence of an amputation at inclusion

    Time frame: Day 0

    YES/NO (or, if planned, time to amputation in days).

  61. G. Estimated incidence of amputations

    Time frame: Month 12

    YES/NO (or, if planned, time to amputation in days).

  62. G. Presence of an amputation

    Time frame: Month 24

    YES/NO (or, if planned, time to amputation in days).

  63. H. Precarity of patients with chronic Charcot foot.

    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.

  64. H. Precarity of patients with chronic Charcot foot.

    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.

  65. H. Precarity of patients with chronic Charcot foot.

    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.

  66. I. Depression according to the PHQ-2 self-questionnaire

    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.

  67. I. Depression according to the PHQ-2 self-questionnaire

    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.

  68. I. Depression according to the PHQ-2 self-questionnaire

    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.

  69. I. Depression according to the PHQ-9 self-questionnaire

    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.

  70. I. Depression according to the PHQ-9 self-questionnaire

    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.

  71. I. Depression according to the PHQ-9 self-questionnaire

    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.

  72. J. Mortality rate

    Time frame: Month 12

    Vital status (dead/alive)

  73. J. Mortality rate

    Time frame: Month 24

    Vital status (dead/alive)

  74. K. Sanders Classification of the Charcot Foot

    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.

  75. K. Sanders Classification of the Charcot Foot

    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.

Other outcomes

  1. Sex of patients

    Time frame: Day 0

    MALE/FEMALE

  2. Age of patients

    Time frame: Day 0

    In years

  3. Patient's personal situation

    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

  4. Patient's personal situation

    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

  5. Patient's personal situation

    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

  6. Patient's level of education

    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)

    • 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).
  7. Patient's level of education

    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)

    • 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).
  8. Patient's level of education

    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)

    • 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).
  9. Patient's professional activity

    Time frame: Day 0

    The patient's professional activity (if any) will be recorded

  10. Patient's professional activity

    Time frame: Month 12

    The patient's professional activity (if any) will be recorded

  11. Patient's professional activity

    Time frame: Month 24

    The patient's professional activity (if any) will be recorded

  12. Nature of diabetes

    Time frame: Day 0

    The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).

  13. Nature of diabetes

    Time frame: Month 12

    The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).

  14. Nature of diabetes

    Time frame: Month 24

    The nature of the patient's diabetes will be recorded (Type 1, Type 2, unknown, other).

  15. Age of diabetes

    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).

  16. Age of diabetes

    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).

  17. Age of diabetes

    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).

  18. Presence of other complications: Retinopathy

    Time frame: Day 0

    YES/NO

  19. Presence of other complications: Retinopathy

    Time frame: Month 12

    YES/NO

  20. Presence of other complications: Retinopathy

    Time frame: Month 24

    YES/NO

  21. Presence of other complications: decreased visual acuity

    Time frame: Day 0

    YES/NO

  22. Presence of other complications: decreased visual acuity

    Time frame: Month 12

    YES/NO

  23. Presence of other complications: decreased visual acuity

    Time frame: Month 24

    YES/NO

  24. Presence of other complications: Nephropathy

    Time frame: Day 0

    YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)

  25. Presence of other complications: Nephropathy

    Time frame: Month 12

    YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)

  26. Presence of other complications: Nephropathy

    Time frame: Month 24

    YES/NO and the nature thereof (Insipid nephropathy / Proteinuric nephropathy / Chronic kidney failure)

  27. Presence of other complications: Abnormal glomerular filtration rate (GFR)

    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

  28. Presence of other complications: Abnormal glomerular filtration rate (GFR)

    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

  29. Presence of other complications: Abnormal glomerular filtration rate (GFR)

    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

  30. Presence of other complications: dialysis

    Time frame: Day 0

    YES/NO

  31. Presence of other complications: dialysis

    Time frame: Month 12

    YES/NO

  32. Presence of other complications: dialysis

    Time frame: Month 24

    YES/NO

  33. Presence of other complications: peripheral neuropathy

    Time frame: Day 0

    YES/NO and the nature thereof: monofilament (normal, pathological, not done)

  34. Presence of other complications: peripheral neuropathy

    Time frame: Month 12

    YES/NO and the nature thereof: monofilament (normal, pathological, not done)

  35. Presence of other complications: peripheral neuropathy

    Time frame: Month 24

    YES/NO and the nature thereof: monofilament (normal, pathological, not done)

  36. Presence of other complications: vegetative neuropathy

    Time frame: Day 0

    YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)

  37. Presence of other complications: vegetative neuropathy

    Time frame: Month 12

    YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)

  38. Presence of other complications: vegetative neuropathy

    Time frame: Month 24

    YES/NO and the nature thereof: (bladder, digestive, erectile dysfunction, orthostatic arterial hypotension)

  39. Presence of other complications: coronaropathy

    Time frame: Day 0

    YES/NO

  40. Presence of other complications: coronaropathy

    Time frame: Month 12

    YES/NO

  41. Presence of other complications: coronaropathy

    Time frame: Month 24

    YES/NO

  42. Presence of other complications: heart failure

    Time frame: Day 0

    YES/NO

  43. Presence of other complications: heart failure

    Time frame: Month 12

    YES/NO

  44. Presence of other complications: heart failure

    Time frame: Month 24

    YES/NO

  45. Presence of other complications: arteriopathy of the lower limbs

    Time frame: Day 0

    YES/NO and the nature thereof (revascularised or not/left or right side)

  46. Presence of other complications: arteriopathy of the lower limbs

    Time frame: Month 12

    YES/NO and the nature thereof (revascularised or not/left or right side)

  47. Presence of other complications: arteriopathy of the lower limbs

    Time frame: Month 24

    YES/NO and the nature thereof (revascularised or not/left or right side)

  48. Presence of other complications: involvement of the supra-aortic trunk

    Time frame: Day 0

    YES/NO

  49. Presence of other complications: involvement of the supra-aortic trunk

    Time frame: Month 12

    YES/NO

  50. Presence of other complications: involvement of the supra-aortic trunk

    Time frame: Month 24

    YES/NO

  51. Presence of other complications: stroke

    Time frame: Day 0

    YES/NO

  52. Presence of other complications: stroke

    Time frame: Month 12

    YES/NO

  53. Presence of other complications: stroke

    Time frame: Month 24

    YES/NO

  54. Presence of other complications: sequellar hemiplegia

    Time frame: Day 0

    YES/NO

  55. Presence of other complications: sequellar hemiplegia

    Time frame: Month 12

    YES/NO

  56. Presence of other complications: sequellar hemiplegia

    Time frame: Month 24

    YES/NO

  57. Treatments: oral antidiabetics

    Time frame: Day 0

    The nature of all oral antidiabetics will be recorded.

  58. Treatments: oral antidiabetics

    Time frame: Month 12

    The nature of all oral antidiabetics will be recorded.

  59. Treatments: oral antidiabetics

    Time frame: Month 24

    The nature of all oral antidiabetics will be recorded.

  60. Treatments: injectable antidiabetics

    Time frame: Day 0

    The nature of all injectable antidiabetics will be recorded.

  61. Treatments: injectable antidiabetics

    Time frame: Month 12

    The nature of all injectable antidiabetics will be recorded.

  62. Treatments: injectable antidiabetics

    Time frame: Month 24

    The nature of all injectable antidiabetics will be recorded.

  63. Other treatments

    Time frame: Day 0

    The nature of all other treatments will be recorded.

  64. Other treatments

    Time frame: Month 12

    The nature of all other treatments will be recorded.

  65. Other treatments

    Time frame: Month 24

    The nature of all other treatments will be recorded.

  66. History of trophic disorders

    Time frame: Day 0

    YES/NO and, if so, left/right, both feet.

  67. History of trophic disorders

    Time frame: Month 12

    YES/NO and, if so, left/right, both feet.

  68. History of trophic disorders

    Time frame: Month 24

    YES/NO and, if so, left/right, both feet.

  69. Regular pedicure treatments

    Time frame: Day 0

    The number and frequency of pedicure sessions per year will be recorded (if any).

  70. Regular pedicure treatments

    Time frame: Month 12

    The number and frequency of pedicure sessions per year will be recorded (if any).

  71. Regular pedicure treatments

    Time frame: Month 24

    YES/NO and, if so, number and frequency of pedicure sessions per year will be recorded (if any).

  72. Weight

    Time frame: Day 0

    Kilos

  73. Weight

    Time frame: Month 12

    Kilos

  74. Weight

    Time frame: Month 24

    Kilos

  75. Height

    Time frame: Day 0

    Centimeters

  76. Height

    Time frame: Month 12

    Centimeters

  77. Height

    Time frame: Month 24

    Centimeters

  78. Charcot foot

    Time frame: Day 0

    Left/right/both

  79. Charcot foot

    Time frame: Month 12

    Left/right/both

  80. Charcot foot

    Time frame: Month 24

    Left/right/both

  81. Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy

    Time frame: Day 0

    In years

  82. Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy

    Time frame: Month 12

    In years

  83. Estimated age of lesions (deformities) caused by neurogenic osteoarthropathy

    Time frame: Month 24

    In years

  84. Neurogenic osteoarthropathy Sanders classification

    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

  85. Neurogenic osteoarthropathy Sanders classification

    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

  86. Neurogenic osteoarthropathy Sanders classification

    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

  87. Current mode of shoeing/unfastening at home

    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...

  88. Current mode of shoeing/unfastening outdoors

    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...

  89. Current mode of shoeing/unfastening at home

    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...

  90. Current mode of shoeing/unfastening outdoors

    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...

  91. Current mode of shoeing/unfastening at home

    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...

  92. Current mode of shoeing/unfastening outdoors

    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...

  93. Adherence to shoeing method

    Time frame: Day 0

    At home/outdoors

  94. Adherence to shoeing method

    Time frame: Month 12

    At home/outdoors

  95. Adherence to shoeing method

    Time frame: Month 24

    At home/outdoors

  96. Presence of another trophic foot disorder during the previous year

    Time frame: Day 0

    YES/NO and date of onset of the ulcer (month and year)

  97. Presence of another trophic foot disorder during the previous year

    Time frame: Month 12

    YES/NO and date of onset of the ulcer (month and year)

  98. Presence of another trophic foot disorder during the previous year

    Time frame: Month 24

    YES/NO and date of onset of the ulcer (month and year)

  99. Presence of a clinical infection

    Time frame: Day 0

    YES/NO and, if so, the Infectious Diseases Society of America classification

  100. Presence of a clinical infection

    Time frame: Month 12

    YES/NO and, if so, the Infectious Diseases Society of America classification

  101. Presence of a clinical infection

    Time frame: Month 24

    YES/NO and, if so, the Infectious Diseases Society of America classification

  102. Foot or leg surgery in the previous year

    Time frame: Day 0

    YES/NO and, if so, left/right

  103. Foot or leg surgery in the previous year

    Time frame: Month 12

    YES/NO and, if so, left/right

  104. Foot or leg surgery in the previous year

    Time frame: Month 24

    YES/NO and, if so, left/right

  105. Partial foot amputation

    Time frame: Day 0

    YES/NO and, if so, left/right

  106. Partial foot amputation

    Time frame: Month 12

    YES/NO and, if so, left/right

  107. Partial foot amputation

    Time frame: Month 24

    YES/NO and, if so, left/right

  108. Trans-tibial amputation

    Time frame: Day 0

    YES/NO and, if so, left/right

  109. Trans-tibial amputation

    Time frame: Month 12

    YES/NO and, if so, left/right

  110. Trans-tibial amputation

    Time frame: Month 24

    YES/NO and, if so, left/right

  111. Trans-femoral amputation

    Time frame: Day 0

    YES/NO and, if so, left/right

  112. Trans-femoral amputation

    Time frame: Month 12

    YES/NO and, if so, left/right

  113. Trans-femoral amputation

    Time frame: Month 24

    YES/NO and, if so, left/right

  114. Other type of surgery

    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.

  115. Other type of surgery

    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.

  116. Other type of surgery

    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.

  117. Hospitalization in the previous year

    Time frame: Day 0

    YES/NO and, if so, the reason why

  118. Hospitalization in the previous year

    Time frame: Month 12

    YES/NO and, if so, the reason why

  119. Hospitalization in the previous year

    Time frame: Month 24

    YES/NO and, if so, the reason why

  120. Onset and management of a foot wound (medical or surgical)

    Time frame: Day 0

    YES/NO and dates

  121. Onset and management of a foot wound (medical or surgical)

    Time frame: Month 12

    YES/NO and dates

  122. Onset and management of a foot wound (medical or surgical)

    Time frame: Month 24

    YES/NO and dates

  123. Management of a Charcot foot

    Time frame: Day 0

    YES/NO

  124. Management of a Charcot foot

    Time frame: Month 12

    YES/NO

  125. Management of a Charcot foot

    Time frame: Month 24

    YES/NO

  126. Onset of a controlateral Charcot foot

    Time frame: Day 0

    YES/NO

  127. Onset of a controlateral Charcot foot

    Time frame: Month 12

    YES/NO

  128. Onset of a controlateral Charcot foot

    Time frame: Month 24

    YES/NO

  129. Diabetic imbalance

    Time frame: Day 0

    YES/NO

  130. Diabetic imbalance

    Time frame: Month 12

    YES/NO

  131. Diabetic imbalance

    Time frame: Month 24

    YES/NO

  132. Other comorbidity or other reason for surgery

    Time frame: Day 0

    YES/NO

  133. Other comorbidity or other reason for surgery

    Time frame: Month 12

    YES/NO

  134. Other comorbidity or other reason for surgery

    Time frame: Month 24

    YES/NO

  135. Monitoring of glycemic control by HbA1c

    Time frame: Day 0

    HbA1c will be measured as a percentage

  136. Monitoring of glycemic control by HbA1c

    Time frame: Month 12

    HbA1c will be measured as a percentage

  137. Monitoring of glycemic control by HbA1c

    Time frame: Month 24

    HbA1c will be measured as a percentage

  138. Monitoring of glomerular Filtration Rate

    Time frame: Day 0

    ml/mn

  139. Monitoring of glomerular Filtration Rate

    Time frame: Month 12

    ml/mn

  140. Monitoring of glomerular Filtration Rate

    Time frame: Month 24

    ml/mn

  141. X-ray of Charcot foot under loading (profile view)

    Time frame: Day 0

    Measurement of the Djian Annonier angle and the Meary-Tomeno line

  142. X-ray of Charcot foot under loading (profile view)

    Time frame: Month 12

    Measurement of the Djian Annonier angle and the Meary-Tomeno line

  143. X-ray of Charcot foot under loading (profile view)

    Time frame: Month 24

    Measurement of the Djian Annonier angle and the Meary-Tomeno line

  144. Front view X-ray of the ankle(s) under loading

    Time frame: Day 0

    With Meary cerclage (metal cerclage of the hindfoot)

  145. Front view X-ray of the ankle(s) under loading

    Time frame: Month 12

    With Meary cerclage (metal cerclage of the hindfoot)

  146. Front view X-ray of the ankle(s) under loading

    Time frame: Month 24

    With Meary cerclage (metal cerclage of the hindfoot)

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33 4.66.68.42.36

Sophie Schuldiner, Dr.

CONTACT

[email protected]

+33 4.66.68.33.21

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot

Acronym: CHARQUAM

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 8, 2022
Registry last updated
Aug 13, 2024

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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