Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
CHARQUAM
Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
1 other identifier
observational
150
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
January 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 22, 2028
August 13, 2024
August 1, 2024
4.5 years
July 29, 2022
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Results of the SF36 questionnaire at inclusion
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Day 0
Results of the FAAM-F questionnaire at inclusion
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Day 0
Results of the SF36 questionnaire at Month 12
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Month 12
Results of the FAAM-F questionnaire at Month 12
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Month 12
Results of the SF36 questionnaire at Month 24
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Month 24
Results of the FAAM-F questionnaire at Month 24
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Month 24
Secondary Outcomes (75)
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
Day 0
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
Month 12
A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)
Month 24
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.
Day 0
A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.
Month 12
- +70 more secondary outcomes
Other Outcomes (146)
Sex of patients
Day 0
Age of patients
Day 0
Patient's personal situation
Day 0
- +143 more other outcomes
Interventions
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.
Eligibility Criteria
The source population corresponds to all diabetic patients (Type 1, 2 or secondary diabetes) hospitalized or consulting for chronic diabetic osteoarthropathy of the nerves, without wound managed in the participating centers.
You may qualify if:
- 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).
You may not qualify if:
- 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 under court protection, guardianship or trusteeship.
- patients for whom it is impossible to give informed information.
- pregnant, parturient, or breastfeeding patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, Pas-de-Calais, 62200, France
Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine
Bron, 69500, France
CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault
Corbeil-Essonnes, 91100, France
CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins
Grenoble, 38043, France
Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur
Le Creusot, 71200, France
CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc
Le Kremlin-Bicêtre, 94275, France
CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,
Lens, 62307, France
CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski
Lille, 59037, France
CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille
Marseille, 13005, France
CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud
Montpellier, 34295, France
GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital
Paris, 750013, France
GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand
Paris, 75014, France
Hôpital Cochin Service de diabétologie 123 Bd de Port Royal
Paris, 75014, France
CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet
Pierre-Bénite, 69495, France
CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig
Reims, 51092, France
Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital,
Strasbourg, 61091, France
Hôpital DRON Service de diabétologie 135 rue du Président Coty
Tourcoing, 52208, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 8, 2022
Study Start
January 23, 2023
Primary Completion (Estimated)
July 22, 2027
Study Completion (Estimated)
January 22, 2028
Last Updated
August 13, 2024
Record last verified: 2024-08