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NCT05491577 | RECRUITING | Charcot Joint of Foot


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

Nīmes University Hospital Center

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.

Condition or disease

Charcot Joint of Foot

Osteoarthropathy

Intervention/treatment

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

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
Actual Study Start Date : 2023-01-23
Estimated Primary Completion Date : 2027-07-22
Estimated Study Completion Date : 2028-01-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT05491577


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Locations


NOT YET RECRUITING

France, Pas-de-Calais

Boulogne-sur-Mer Hospital Center

Boulogne-sur-Mer, Pas-de-Calais, France, 62200

NOT YET RECRUITING

France,

Eastern Hospital Group, Cardiological Hospital Diabetology Department 28 Av du Doyen Lépine

Bron, France, 69500

NOT YET RECRUITING

France,

CH Sud Francilien Diabetology Department 40 Avenue Serge Dassault

Corbeil-Essonnes, France, 91100

NOT YET RECRUITING

France,

Grenoble University Hospital Department of Endocrinology Allée des Sablons Les écrins

Grenoble, France, 38043

NOT YET RECRUITING

France,

Hospital Hôtel Dieu Endocrinology Department 26 rue d’Harfleur

Le Creuset, France, 71200

RECRUITING

France,

CHU Bicêtre Department of Endocrinology and Reproductive Diseases 78 rue du Général Leclerc

The Kremlin-Bicêtre, France, 94275

RECRUITING

France,

CH of Lens Unit of Diabetology-Endocrinology-Nutrition-Obesity Hospital Center Dr SCHAFFNER 99 rte de La Bassée,

Lens, France, 62307

NOT YET RECRUITING

France,

CHRU of Lille Department of Endocrinology Diabetology and Metabolism, Claude Huriez Hospital, Rue Polonovski

Lille, France, 59037

NOT YET RECRUITING

France,

CHU de la CONCEPTION Department of Nutrition, Diabetology, Medical and surgical obesity 47 Bd Baille

Marseille, France, 13005

RECRUITING

France,

Montpellier University Hospital Department of Metabolic Diseases 371 av. Dean Giraud

Montpellier, France, 34295

RECRUITING

France,

GH Pitié Salpétrière Podiatry Unit Diabetology Department 47-83 Bd de l’Hôpital

Paris, France, 750013

RECRUITING

France,

GH Paris Saint Joseph Department of Diabetology and Endocrinology 185 rue Raymond Losserand

Paris, France, 75014

NOT YET RECRUITING

France,

Cochin Hospital Diabetology Department 123 Bd de Port Royal

Paris, France, 75014

RECRUITING

France,

Lyon Sud University Hospital Department of Endocrinology-Diabetes-Nutrition CH Lyon Sud Medical Pavilion, Bat 1B 165 chemin du Grand Revoyet

Pierre-Bénite, France, 69495

RECRUITING

France,

CHU Reims Department of Endocrinology, diabetes-nutrition Rue du Général Koenig

Reims, France, 51092

NOT YET RECRUITING

France,

University Hospitals of Strasbourg Department of Endocrinology and Diabetology 1, place de l’Hôpital,

Strasbourg, France, 61091

RECRUITING

France,

DRON Hospital Diabetology Department 135 rue du Président Coty

Tourcoing, France, 52208

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