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.

INTRODUCTION: The 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 METHODS: The 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. RESULTS: Among 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). CONCLUSIONS: Orthèse 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 NUMBER: NCT01956162.

Outpatient measurement of arterial stiffness in patients with type 2 diabetes and obesity.

BACKGROUND: Pulse wave velocity (PWV) is a marker of arterial stiffness. The aim of the present study was to compare PWV in patients with type 2 diabetes mellitus (T2DM) or obesity and healthy subjects in an outpatient setting. METHODS: A cross-sectional study was conducted in patients with obesity without T2DM (n = 37), T2DM without obesity (n = 40), T2DM plus obesity (n = 43), and healthy controls (n = 114). Outpatient measurements of the finger-toe PWV (ftPWV) were made. RESULTS: Mean (± SD) ftPWV was higher in men than in women (10.57 ± 5.02 vs 9.14 ± 3.68 m/s, respectively P = 0.006) and was positively correlated with age (r2 = 0.31, P < 0.0001), body mass index (r2 = 0.03, P = 0.01), systolic blood pressure (SBP; r2 = 0.06, P < 0.0001), and right (r2 = 0.03, P = 0.01) and left (r2 = 0.03, P = 0.01) ankle-brachial index (ABI). Age, SBP and ABI remained significantly correlated with ftPWV in the stepwise regression analysis. Mean ftPWV in controls and in patients with obesity, T2DM, and T2DM plus obesity was 8.32 ± 2.68, 9.50 ± 3.38, 11.29 ± 4.34, and 12.36 ± 6.67 m/s, respectively (P < 0.0001). These differences remained significant after adjustments for sex, age, SBP, and ABI (P = 0.008). Although ftPWV was higher in patients with than without macrovascular complications (13.11 ± 6.25 vs 10.40 ± 4.54 m/s, respectively; P = 0.006) in univariate analysis, this was not so in the multivariate-adjusted model. CONCLUSIONS: Outpatient-measured ftPWV was correlated with age, SBP, and ABI. It was higher in patients with T2DM and obesity compared with healthy controls. The highest ftPWV was observed in patients with both T2DM and obesity.

The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational.

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/DESIGN: 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. CONCLUSION: ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).