title: The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational.
abstract: BACKGROUND
  Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot.
  
  
  METHODS
  ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017.
  
  
  CONCLUSIONS
  ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France ; INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.
authors.forename: Kamel
authors.initials: K
authors.lastname: Mohammedi
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France ; INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France ; Université Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Potier
authors.affiliation: Centre Hospitalier Universitaire de Reims, Service d'Endocrinologie, Diabète, Nutrition, Reims, France.
authors.forename: Maud
authors.initials: M
authors.lastname: François
authors.affiliation: Department of Diabetology, Endocrinology and Nutrition, Centre hospitalier Sud Francilien, Corbeil-Essonnes, France.
authors.forename: Dured
authors.initials: D
authors.lastname: Dardari
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
authors.forename: Marilyne
authors.initials: M
authors.lastname: Feron
authors.affiliation: Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Estelle
authors.initials: E
authors.lastname: Nobecourt-Dupuy
authors.affiliation: Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.
authors.forename: Manuel
authors.initials: M
authors.lastname: Dolz
authors.affiliation: APHP, Hôpital Corentin-Celton, Centre de Cicatrisation du Pied du Diabétique, Issy-les-Moulineaux, France.
authors.forename: Roxane
authors.initials: R
authors.lastname: Ducloux
authors.affiliation: Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier de Gonesse, Gonesse, France.
authors.forename: Abdelkader
authors.initials: A
authors.lastname: Chibani
authors.affiliation: Department of functional rehabilitation, Centre Hospitalier La Tourmaline, Saint Herblain, France.
authors.forename: Dominique-François
authors.initials: DF
authors.lastname: Eveno
authors.affiliation: Department of Diabetology, Centre Hospitalier Régional de Metz - Thionville, Endocrinology and Nutrition, Thionville, France.
authors.forename: Teresa
authors.initials: T
authors.lastname: Crea Avila
authors.affiliation: Endocrinology-Diabetology-Nutrition Department, CHRU Montpellier, Montpellier, France ; INSERM U1046, University of Montpellier 1, Montpellier, France.
authors.forename: Ariane
authors.initials: A
authors.lastname: Sultan
authors.affiliation: Nutrition and Diabetology Unit, CHU de Bordeaux, Haut Lévèque Hospital, Pessac, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Baillet-Blanco
authors.affiliation: Nutrition and Diabetology Unit, CHU de Bordeaux, Haut Lévèque Hospital, Pessac, France ; University of Bordeaux, Bordeaux, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Rigalleau
authors.affiliation: INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.
authors.forename: Gilberto
authors.initials: G
authors.lastname: Velho
authors.affiliation: Département d'Epidémiologie et Recherche Clinique, APHP, CIC-EC 1425, Centre de Pharmacoépidémiologie (Cephepi), Paris, France ; Université Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Tubach
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France ; INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France ; Université Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
authors.forename: Ronan
authors.initials: R
authors.lastname: Roussel
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Dupré
authors.affiliation: Centre Hospitalier Universitaire de Reims, Service d'Endocrinologie, Diabète, Nutrition, Reims, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Malgrange
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition, DHU FIRE, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France ; INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France ; Université Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Marre
mesh_terms: D000671:Amputation, Surgical / Q000534:rehabilitation; D017719:Diabetic Foot / Q000503:physiopathology / Q000534:rehabilitation* / Q000601:surgery; D004867:Equipment Design; D061826:Foot Orthoses; D006801:Humans; D017060:Patient Satisfaction; D011312:Pressure; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome; D016474:Weight-Bearing / Q000502:physiology; D014945:Wound Healing
keywords: Device; Diabetic foot; Healing; Off-loading; Wound