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

Last updated: August 12, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

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

Clinical Study ID

NCT05491577
SI RIPH 2G : 22.01571.000083
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
Phase:
Study Start date:
January 23, 2023
Estimated Completion Date:
January 22, 2028

Study 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.

Connect with a study center

  • Centre Hospitalier de Boulogne-sur-Mer

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

    Site Not Available

  • Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine

    Bron, 69500
    France

    Site Not Available

  • CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins

    Grenoble, 38043
    France

    Site Not Available

  • Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur

    Le Creusot, 71200
    France

    Site Not Available

  • CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc

    Le Kremlin-Bicêtre, 94275
    France

    Active - Recruiting

  • CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée,

    Lens, 62307
    France

    Active - Recruiting

  • CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski

    Lille, 59037
    France

    Site Not Available

  • CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille

    Marseille, 13005
    France

    Site Not Available

  • CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud

    Montpellier Cedex, 34295
    France

    Active - Recruiting

  • GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand

    Paris, 75014
    France

    Active - Recruiting

  • GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital

    Paris, 750013
    France

    Active - Recruiting

  • Hôpital Cochin Service de diabétologie 123 Bd de Port Royal

    Paris, 75014
    France

    Site Not Available

  • 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

    Active - Recruiting

  • CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig

    Reims, 51092
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital,

    Strasbourg, 61091
    France

    Site Not Available

  • Hôpital DRON Service de diabétologie 135 rue du Président Coty

    Tourcoing, 52208
    France

    Active - Recruiting

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