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.

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).

Screening Genetic Resources of Capsicum Peppers in Their Primary Center of Diversity in Bolivia and Peru.

For most crops, like Capsicum, their diversity remains under-researched for traits of interest for food, nutrition and other purposes. A small investment in screening this diversity for a wide range of traits is likely to reveal many traditional varieties with distinguished values. One objective of this study was to demonstrate, with Capsicum as model crop, the application of indicators of phenotypic and geographic diversity as effective criteria for selecting promising genebank accessions for multiple uses from crop centers of diversity. A second objective was to evaluate the expression of biochemical and agromorphological properties of the selected Capsicum accessions in different conditions. Four steps were involved: 1) Develop the necessary diversity by expanding genebank collections in Bolivia and Peru; 2) Establish representative subsets of ~100 accessions for biochemical screening of Capsicum fruits; 3) Select promising accessions for different uses after screening; and 4) Examine how these promising accessions express biochemical and agromorphological properties when grown in different environmental conditions. The Peruvian Capsicum collection now contains 712 accessions encompassing all five domesticated species (C. annuum, C. chinense, C. frutescens, C. baccatum, and C. pubescens). The collection in Bolivia now contains 487 accessions, representing all five domesticates plus four wild taxa (C. baccatum var. baccatum, C. caballeroi, C. cardenasii, and C. eximium). Following the biochemical screening, 44 Bolivian and 39 Peruvian accessions were selected as promising, representing wide variation in levels of antioxidant capacity, capsaicinoids, fat, flavonoids, polyphenols, quercetins, tocopherols, and color. In Peru, 23 promising accessions performed well in different environments, while each of the promising Bolivian accessions only performed well in a certain environment. Differences in Capsicum diversity and local contexts led to distinct outcomes in each country. In Peru, mild landraces with high values in health-related attributes were of interest to entrepreneurs. In Bolivia, wild Capsicum have high commercial demand.

Germination and embryo rescue from Passiflora species seeds post-cryopreservation.

Seeds of Passiflora species have been reported to have intermediate or orthodox storage behavior. The development of cryopreservation protocols for recalcitrant or intermediate seeds can provide a feasible way for long term germplasm conservation. Seed germination of three Passiflora species (P. pinnatistipula, P. tarminiana and P. mollissima) was studied after desiccation and cryopreservation. The three species showed an intermediate response to desiccation: at 3-3.5% water content their germination was reduced to 23-45%, with P. pinnatistipula showing the maximum desiccation tolerance (62% germination after drying to 4.2% water content). The safest seed water contents for cryopreservation: 4.5-4.8% for P. pinnatistipula and P. mollissima, and 9% for P. tarminiana, resulting in 84%, 73%, and 63% germination, respectively. This is the first report of seed cryopreservation for these species.

El programa de diagnóstico, manejo y prevención de enfermedades genéticas y defectos congénitos en la provincia Holguín: 1987-2008 / The program for the diagnosis, management and prevention of genetic diseases and congenital defects in Holguín province 1987-2008

Se resume brevemente los primeros 22 años de trabajo de los servicios de genética médica en la provincia Holguín y se muestran los principales resultados del programa de diagnóstico, manejo y prevención de enfermedades genéticas y defectos congénitos en esta provincia en el período 1987-2008. Se revisaron los registros clínicos disponibles en el Centro Provincial de Genética Médica de Holguín desde 1987 hasta el 2008 en cada uno de los programas asistenciales que se ofrecen en los servicios de genética médica de la provincia. Por el programa de detección de portadoras de anemia por hematíes falciformes para la prevención de la enfermedad han sido estudiadas 327 484 gestantes, de ellas 9 358 son portadoras de la enfermedad. Se identificaron 346 parejas de riesgo en las que el feto podría resultar enfermo, y se les ofreció la posibilidad de realizar el diagnóstico prenatal. La alfafetoproteína en suero materno ha sido realizada a 306 413 gestantes en la provincia desde los inicios del programa hasta la actualidad. En 543 gestaciones en las que se obtuvo valores alterados de la alfafetoproteína, se confirmó por ultrasonido la presencia de un defecto congénito en el feto, lo que muestra una incidencia de 1,77 por cada 1 000 embarazos en el período estudiado. El programa de diagnóstico prenatal citogenético para gestantes con riesgo incrementado de descendientes con anomalías cromosómicas atendió a 4 113 gestantes y en 89 casos los resultados han sido positivos. En este período además se han diagnosticado defectos congénitos severos en 1 939 fetos por ultrasonido. Este programa alcanza una cobertura superior al 98(percent) de los recién nacidos a estudiar. Un grupo importantes de investigaciones han sido desarrolladas en las áreas de salud de la provincia durante este período como parte del trabajo de los Másteres en Asesoramiento Genético…(AU)

Management of the appropriate agricultural biotechnology for small producers: Bolivia case study

The Bolivia study is part of an ongoing multiple case study organized by the FAO's Regional Office for Latin America and the Caribbean as part of the activities of the Technical Cooperation Network on Agricultural Biotechnology (REDBIO/FAO). The basic information was obtained through a survey and/or direct interview to a significant number of experts from Bolivian institutions involving management, regulation, research, innovation, application and education of agricultural biotechnology. At national level, the most relevant applied agri-biotechnologies are presently in vitro plant culture, genomics, molecular genetics, assisted reproduction techniques in animals, and techniques supporting plant and animal disease diagnosis. They have been developed and appropriated to support the agricultural sector including genetically modified crops. Over the past ten years, the public research and academic institutions have allocated resources to implement laboratories and others have widened and updated their facilities. Nonetheless, a different situation is observed in the private sector where some laboratories have been forced to close down and to reduce production due to the economic crisis of the country. In view of the country's specific needs and opportunities regarding conservation and utilization of genetic resources, biotechnology can constitute a valuable tool for the sustainable development of the country.

Programa de oxigenoterapia domiciliaria INERYCT / INERYCT domiciliary oxygen therapy program

La EBOC y la insuficiencia respiratoria crónica constituyen un problema importante de Salud Pública. Ha sido demostrado que la oxigenoterapia continua, mejora tanto la sobrevida como la calidad de vida de estos pacientes. Por esta razón, a partir de 1984 se inició la organización e implementación de un Programa de Oxigenoterapia (OD), dependiente del Servicio de Medicina del INERCYCT, que al momento actual dispone de una estructura operacionalmente eficiente. Los criterios de selección para ingresar pacientes al programa fueron: PaO2 <55 mmHg y ausencia de patología asociada grave y de hábitos nocivos. Se han evaluado 47 pacientes portadores de EBOC, de los cuales 16 fueron ingresados al estudio. Seis meses Post OD, observamos, disminución tanto de la frecuencia de hospitalizaciones como del número de días/cama, no observándose cambios en las espirometrías, PaO2, PaCO2 y ECG. Sin embargo, encontramos mejoría en la calidad de vida, objetivada a través de una entrevista psiquiátrica, lo cual a la luz de estudios previos, se podría atribuir a la oxigenoterapia aportada