Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
NCT ID: NCT05491577
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-01-23
2028-01-22
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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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, , 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 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, , France
Countries
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Central Contacts
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Facility Contacts
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Myriam MORET, Dr
Role: primary
Dured DARDARI, Dr.
Role: primary
Marie Muller, Dr.
Role: primary
Haleh MOHEBBI, Dr.
Role: primary
Muriel BOURGEON, Dr
Role: primary
Fabrice DEVEMY, Dr
Role: primary
Florence BAUDOUX, Dr.
Role: primary
Rachel GRANGEOT-PATTE, Dr.
Role: primary
Ariane SULTAN, Pr
Role: primary
Georges HA VAN, Dr.
Role: primary
Olivier DUPUY, Dr.
Role: primary
Jocelyne MBEMBA, Dr
Role: primary
Julien VOUILLARMET, Dr.
Role: primary
Maud FRANCOIS, Dr.
Role: primary
Laurence KESSLER, Dr.
Role: primary
Marie CAZAUBIEL, Dr.
Role: primary
Other Identifiers
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SI RIPH 2G : 22.01571.000083
Identifier Type: -
Identifier Source: org_study_id
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