Evaluating quality of life in diabetic patients with chronic Charcot foot
Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
This study looks at how living with chronic Charcot foot affects the quality of life for people with diabetes over two years to see what factors might lead to worse outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 17 sites (Boulogne-sur-Mer, Pas-de-Calais and 16 other locations) |
| Trial ID | NCT05491577 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the evolution of quality of life over two years in patients with chronic Charcot foot, a complication of diabetes. It will involve a multicenter cohort of patients in France, focusing on identifying predictive factors that contribute to deterioration in quality of life. The study will utilize various questionnaires, including the SF-36 and FAAM-F, to gather data on foot and ankle functionality, deformities, and other comorbidities. The goal is to better understand the impact of chronic Charcot foot on patients' lives and identify those at higher risk for poor outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Type 1 or Type 2 diabetes who are experiencing chronic osteoarthropathy without foot wounds.
Not a fit: Patients with non-diabetic osteoarthropathy, acute diabetic osteoarthropathy, or those with foot ulcers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for diabetic patients suffering from chronic Charcot foot, enhancing their quality of life.
How similar studies have performed: While there is limited data on similar studies, the approach of evaluating quality of life in chronic Charcot foot patients is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boulogne-sur-Mer, Pas-de-Calais and 16 other locations
- Centre Hospitalier de Boulogne-sur-Mer — Boulogne-sur-Mer, Pas-de-Calais, France (Not_yet_recruiting)
- Groupement Hospitalier Est, Hôpital Cardiologique Service de Diabétologie 28 Av du Doyen Lépine — Bron, France (Not_yet_recruiting)
- CH Sud Francilien Service de Diabétologie 40 Avenue Serge Dassault — Corbeil-Essonnes, France (Not_yet_recruiting)
- CHU de Grenoble Service d'Endocrinologie Allée des Sablons Les écrins — Grenoble, France (Not_yet_recruiting)
- Hôpital Hôtel dieu Service d'Endocrinologie 26 rue d'Harfleur — Le Creusot, France (Not_yet_recruiting)
- CHU Bicêtre Service d'Endocrinologie et Maladies de la reproduction 78 rue du Général Leclerc — Le Kremlin-Bicêtre, France (Recruiting)
- CH de Lens Unité de Diabétologie-Endocrinologie- Nutrition-Obésité Centre Hospitalier Dr SCHAFFNER 99 rte de La Bassée, — Lens, France (Recruiting)
- CHRU de Lille Service d'Endocrinologie Diabétologie et Métabolisme, Hôpital Claude Huriez, Rue Polonovski — Lille, France (Not_yet_recruiting)
- CHU de la CONCEPTION Service de Nutrition, Diabétologie, Obésité médicale, chirurgicale 47 Bd Baille — Marseille, France (Not_yet_recruiting)
- CHU de Montpellier Service des Maladies métaboliques 371 av. Doyen Giraud — Montpellier, France (Recruiting)
- GH Pitié Salpétrière Unité de podologie Service de Diabétologie 47-83 Bd de l'Hôpital — Paris, France (Recruiting)
- GH Paris Saint Joseph Service de Diabétologie et Endocrinologie 185 rue Raymond Losserand — Paris, France (Recruiting)
- Hôpital Cochin Service de diabétologie 123 Bd de Port Royal — Paris, France (Not_yet_recruiting)
- CHU de Lyon Sud Service d'Endocrinologie-Diabète-Nutrition CH Lyon Sud Pavillon médical, Bat 1B 165 chemin du Grand Revoyet — Pierre-Bénite, France (Recruiting)
- CHU Reims Service d'Endocrinologie, diabète-nutrition Rue du Général Koenig — Reims, France (Recruiting)
- Hôpitaux Universitaires de Strasbourg Service d'Endocrinologie et Diabétologie 1, place de l'hôpital, — Strasbourg, France (Not_yet_recruiting)
- Hôpital DRON Service de diabétologie 135 rue du Président Coty — Tourcoing, France (Recruiting)
Study contacts
- Study coordinator: Sophie Schuldiner, Dr.
- Email: sophie.schuldiner@chu-nimes.fr
- Phone: +33 4.66.68.33.21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.