Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial
| العنوان: | Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial |
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| المؤلفون: | Maud François, L Bordier, Teresa Crea Avila, Abdelkader Chibani, Louis Potier, Laurence Baillet-Blanco, Narimène Belhatem, Roxane Ducloux, Manuel Dolz, Dured Dardari, Vincent Rigalleau, Ronan Roussel, Estelle Nobecourt-Dupuy, Dominique Malgrange, Ariane Sultan, Dominique-François Eveno, Jean-Claude Dupré, Quentin Pellenc, Marilyne Feron, Michel Marre, Pierre-Jean Saulnier, Gilberto Velho, Elise Gand, Kamel Mohammedi |
| المساهمون: | Service d'endocrinologie, diabétologie et nutrition [CHU Bichat], Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Centre Hospitalier Universitaire de la Réunion, Saint Denis de la Réunion, Hôpital d'Instruction des Armées Begin, Service de Santé des Armées, Hôpital Corentin Celton [Issy-les-Moulineaux], Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier de Gonesse, Centre Hospitalier La Tourmaline, La Tourmaline, Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Service d'Endocrinologie (BORDEAUX - Endocrino), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de Recherche des Cordeliers, Paris, Service d'Endocrinologie - Diabète - Nutrition [Reims], Université de Reims Champagne-Ardenne (URCA)-Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), MORNET, Dominique |
| المصدر: | BMJ Open Diabetes Research & Care BMJ Open Diabetes Research & Care, BMJ Journals, 2020, 8 (1), pp.e000954. ⟨10.1136/bmjdrc-2019-000954⟩ BMJ Open Diabetes Research & Care, 2020, 8 (1), pp.e000954. ⟨10.1136/bmjdrc-2019-000954⟩ BMJ Open Diabetes Research & Care, Vol 8, Iss 1 (2020) |
| بيانات النشر: | HAL CCSD, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, randomized clinical trials, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, [SDV]Life Sciences [q-bio], off-loading devices, 030209 endocrinology & metabolism, Clinical Care/Education/Nutrition, Sudden death, Diseases of the endocrine glands. Clinical endocrinology, Amputation, Surgical, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Diabetes mellitus, medicine, Diabetes Mellitus, Humans, Adverse effect, ComputingMilieux_MISCELLANEOUS, Aged, Wound Healing, business.industry, Middle Aged, RC648-665, medicine.disease, Diabetic foot, Diabetic Foot, foot ulcer, 3. Good health, Surgery, [SDV] Life Sciences [q-bio], Diabetic foot ulcer, medicine.anatomical_structure, Amputation, Ankle, business |
| الوصف: | IntroductionThe offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing.Research, design and methodsThe evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.ResultsAmong 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04).ConclusionsOrthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.Trial registration numberNCT01956162. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2052-4897 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9a8a010ad109c1a804a74d6471c7d23Test https://hal.archives-ouvertes.fr/hal-02573070/documentTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d9a8a010ad109c1a804a74d6471c7d23 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20524897 |
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