Úlceras de pie diabético infectadas con bacterias multirresistentes a los antimicrobianos en pacientes venezolanos / Diabetic Foot Ulcers Infected with Bacteria Multiresistant to Antimicrobials in Venezuelan patients

Introducción: Las úlceras de pie diabético tienen una importante morbimortalidad, más aun, si están asociadas a bacterias multirresistentes a los antimicrobianos. Objetivo: Analizar las características de las úlceras de pie diabético infectadas con bacterias multirresistentes a los antimicrobianos. Métodos: Se realizó una investigación descriptiva, no experimental y transversal, en 87 pacientes con úlceras de pie diabético infectadas, atendidos en una consulta especializada del estado Zulia, Venezuela. Se realizó la anamnesis y exploración física, especialmente centrada en las características de las úlceras de pie diabético. Se obtuvieron muestras de tejido ulceroso para identificar las bacterias presentes y el antimicrobiano correspondiente. Resultados: Todos los pacientes tenían úlcera previa, con agudización de la infección (75,86 por ciento), rehospitalización (59,77 por ciento), amputación previa (36,78 por ciento), úlceras de pie diabético infectadas de larga duración (86,21 por ciento). El 95,40 por ciento recibieron antibióticos previos y 57,62 por ciento habían sido hospitalizados, la antigüedad de la enfermedad fue 16,17 ± 8,41 años y la HbA1c 8,87 ± 1,23. Las úlceras de pie diabético infectadas más frecuente fue neuroisquémica (71,26 por ciento). Predominó la flora monomicrobiana con un (62,07 por ciento) y bacterias gramnegativas (87,36 por ciento). El 79,3 por ciento presentaron bacterias multirresistentes a los antimicrobianos y el 20,69 por ciento panresistencia. Las bacterias multirresistentes fueron predominantemente gramnegativas, y para las grampositivas solo estuvo el Staphylococcus aureus. Conclusiones: Se presenció una alta frecuencia de úlceras de pie diabético infectadas con multirresistencia, predominantemente monomicrobianas y todas con resistencia a betalactámicos y fluoroquinolonas(AU)

Introduction: Diabetic foot ulcers have significant morbidity and mortality, even more so if they are associated with multi-resistant bacteria to antimicrobials. Objective: To analyze the characteristics of diabetic foot ulcers infected with bacteria multi-resistant to antimicrobials. Methods: A descriptive, non-experimental and cross-sectional investigation was carried out in 87 patients with infected diabetic foot ulcers. They were treated in a specialized clinic in Zulia state, Venezuela. Anamnesis and physical examination were performed, especially focused on the characteristics of diabetic foot ulcers. Ulcer tissue samples were obtained to identify the bacteria existing and the corresponding antimicrobial. Results: All the patients had previous ulcer, with exacerbation of the infection (75.86percent), rehospitalization (59.77percent), previous amputation (36.78percent), long-lasting infected diabetic foot ulcers (86.21percent). 95.40percent received previous antibiotics and 57.62percent had been hospitalized, the disease age was 16.17 ± 8.41 years and Hb A1c was 8.87 ± 1.23. The most frequent infected diabetic foot ulcers were neuroischemic (71.26percent). The monomicrobial flora (62.07percent) and gram-negative bacteria (87.36percent) predominated. 79.3percent had multi-resistant bacteria to antimicrobials and 20.69percent pan-resistance. Multi-resistant bacteria were predominantly gram-negative and for gram-positive only staphylococcus aureus. Conclusions: High frequency of multidrug-resistant infected diabetic foot ulcers was found, predominantly monomicrobial and all with resistance to beta-lactams and fluoroquinolones(AU)

Cultivo versus metagenómica para la identificación bacteriana en pacientes con osteomielitis de pie diabético: una revisión sistemática / Culture and metagenomics as bacterial identification methods in patients with diabetic foot ulcers: a systematic review

BACKGROUND: Diabetic foot osteomyelitis (DFO) is a serious complication of infected ulcers in a diabetic patient. The identification of the infecting microorganisms is generally by culture, which causes a bias. Recently, metagenomics has been used for microbial identification. AIM: To systematically review the scientific literature related to DFO in the last 10 years to evaluate if culture and metagenomics are complementary. MATERIAL AND METHODS: To carry out the systematic review, PRISMA and Rayyan were used for the selection of studies, using three databases, using the keywords diabetes, osteomyelitis, culture and microbiome. Articles in English or Spanish were included, containing information related to bacterial identification in DFO. Characteristics of the technique, patients and frequency of bacterial appearance were collected. RESULTS: Twenty six articles were included, 19 used culture and 7 metagenomics. The patients were predominantly men (68%), with an average age of 61 years, 83% had type 2 diabetes and comorbidities, mainly vascular and neuropathy. The Families with the highest frequency of appearance using the culture technique were Enterobacteriaceae (29.3%) and Staphylococcaceae(28.3%) and with metagenomics Peptoniphilaceae (22.1%) and Staphylococcaceae (9.4%). Peptoniphilaceae were not identified in culture, although they were frequently identified by metagenomics. Methicillin- resistant Staphylococcus aureus, regularly identified by culture, was not identified using metagenomics. CONCLUSIONS: Comparing results, there is a certain complementarity between microbiological culture and sequencing to identify bacteria present in DFO.

Research progress in role of autophagy in diabetic wound healing and traditional Chinese medicine intervention / 中国中药杂志

Diabetic ulcer(DU) is a chronic and refractory ulcer which often occurs in the foot or lower limbs. It is a diabetic complication with high morbidity and mortality. The pathogenesis of DU is complex, and the therapies(such as debridement, flap transplantation, and application of antibiotics) are also complex and have long cycles. DU patients suffer from great economic and psychological pressure while enduring pain. Therefore, it is particularly important to promote rapid wound healing, reduce disability and mortality, protect limb function, and improve the quality of life of DU patients. By reviewing the relevant literatures, we have found that autophagy can remove DU wound pathogens, reduce wound inflammation, and accelerate ulcer wound healing and tissue repair. The main autophagy-related factors microtubule-binding light chain protein 3(LC3), autophagy-specific gene Beclin-1, and ubiquitin-binding protein p62 mediate autophagy. The traditional Chinese medicine(TCM) treatment of DU mitigates clinical symptoms, accelerates ulcer wound healing, reduces ulcer recurrence, and delays further deterioration of DU. Furthermore, under the guidance of syndrome differentiation and treatment and the overall concept, TCM treatment harmonizes yin and yang, ameliorates TCM syndrome, and treats underlying diseases, thereby curing DU from the root. Therefore, this article reviews the role of autophagy and major related factors LC3, Beclin-1, and p62 in the healing of DU wounds and the intervention of TCM, aiming to provide reference for the clinical treatment of DU wounds and subsequent in-depth studies.

Evaluation of methanolic crude extract of Linum usitatissimum for the removal of biofilm in diabetic foot isolates / Avaliação do extrato em bruto metanólico de Linum usitatissimum para remoção de biofilmes em isolados diabéticos de pé

Abstract Linum usitatissimum L is a widely used traditionally for multiple ailments. The present research was carried out to explore the antimicrobial, and anti-biofilm activity of crude extract of Linum usitatissimum L (Lu. Cr). Phytochemical and proximate analyses were performed. The bandages of diabetic foot patients were collected from the various hospitals. The bandages were cultured to isolate the bacterial strains present on it. The disc diffusion method was used to identify the antimicrobial potential whereas the minimum inhibitory concentration of the Lu.Cr were also determined. Proximate analysis confirms moisture content 8.33%, ash content 4.33%, crude protein 21.20%, crude fat 49.2% and crude fiber 5.63%. It was revealed that Gram-positive bacteria are most prevalent among all study groups. Lu.Cr possess significant bactericidal potential against S. aureus among all other microbes. Owing to this potential, linseed coated bandages can be used alternatively for the treatment of diabetic foot.

Resumo Linum usitatissimum L é amplamente utilizado tradicionalmente para doenças múltiplas. O presente trabalho foi realizado para explorar a atividade antimicrobiana e antibiofilme do extrato bruto de Linum usitatissimum L (Lu.Cr). Foram realizadas análises fitoquímicas e aproximadas. As ataduras de pacientes diabéticos com pé foram recolhidas nos vários hospitais. As bandagens foram cultivadas para isolar as cepas bacterianas presentes nas mesmas. O método de difusão em disco foi utilizado para identificar o potencial antimicrobiano e a concentração inibitória mínima do Lu.Cr também foi determinada. A análise aproximada confirma o teor de umidade 8,33%, teor de cinzas 4,33%, proteína bruta 21,20%, gordura bruta 49,2% e fibra bruta 5,63%. Foi revelado que as bactérias Gram-positivas são mais prevalentes entre todos os grupos de estudo. Lu.Cr possui potencial bactericida significativo contra S. aureus entre todos os outros micróbios. Devido a esse potencial, as ligaduras revestidas com linhaça podem ser utilizadas alternativamente para o tratamento do pé diabético.

Registro sanitario de Heberprot-P®, medicamento biotecnológico innovador para el tratamiento de las úlceras del pie diabético / Sanitary registration of Heberprot-P®, an innovative biotechnological drug for the treatment of diabetic foot ulcers

Introducción: Heberprot-P® obtuvo su primer registro sanitario en Cuba en el año 2006, actualmente está aprobado en otros 26 países. Objetivo: Describir el proceso de registro sanitario en México, del medicamento biotecnológico Heberprot-P® para el tratamiento de las úlceras del pie diabético. Métodos: El proceso de registro sanitario de Heberprot-P® siguió las pautas de la reglamentación sanitaria de México sobre la base de la Ley general de salud y el Reglamento de insumos para la salud. Se revisaron además la Farmacopea de los Estados Unidos Mexicanos y las normas oficiales mexicanas en función de cumplir las exigencias para la comercialización de medicamentos en este territorio. Resultados: El proceso de registro se inició en junio de 2017 en México con acciones en función de completar los documentos e informaciones exigidas en el expediente de registro sanitario a presentarse. Entre ellos resaltan las consideraciones del Subcomité de Evaluación de Productos Biotecnológicos y el Comité de Moléculas Nuevas, la evaluación del expediente por un Tercero Autorizado y documentos emitidos por el Centro Nacional de Farmacovigilancia e Instituto Mexicano de la Propiedad Industrial. Se presentó la solicitud del registro sanitario ante Cofepris y esta se aprobó en mayo de 2018. Conclusiones: El trabajo con grupos de expertos permitió a la autoridad mexicana hacer un trabajo más expedito basado en las evidencias de las evaluaciones realizadas que son parte de la información del registro sanitario. Como resultado de este proceso, se otorgó el Registro Sanitario a Heberprot-P® en mayo de 2018 y Cofepris lo reconoció como un medicamento biotecnológico innovador(AU)

Introduction: Heberprot-P® obtained its first Sanitary Registration in Cuba in 2006, and it is currently approved in 26 other countries. Objective: Describe the sanitary registration process in Mexico of the biotechnological drug Heberprot-P® for the treatment of diabetic foot ulcers. Methods: The sanitary registration process of Heberprot-P® followed the guidelines of the sanitary regulations of Mexico on the basis of the General Health Law and the Regulation of Supplies for Health. The Pharmacopoeia of the United Mexican States and the official Mexican standards were also revised in order to comply with the requirements for the marketing of medicines in this territory. Results: The registration process began in June 2017 in Mexico with actions to complete the documents and information required in the sanitary registration file to be submitted. Among them are the considerations of the Sub-committee on the Evaluation of Biotechnological Products and the Committee on New Molecules, the evaluation of the file by an Authorized Third Party and documents issued by the National Center for Pharmacovigilance and the Mexican Institute of Industrial Property. The application for sanitary registration was submitted to Cofepris and this was approved in May 2018. Conclusions: The work with groups of experts allowed the Mexican authority to do a more expeditious work based on the evidence of the evaluations carried out that are part of the information of the sanitary registry. As a result of this process, Heberprot-P® was granted the Sanitary Registry in May 2018 and COFEPRIS recognized it as an innovative biotechnological medicine(AU)

Analysis of clinical research outcome indicators of traditional Chinese medicine in treatment of diabetic foot / 中国中药杂志

To analyze the outcome indicators from the randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) treatment for diabetic foot, and to lay a foundation for the establishment of the core index set of the clinical trials on TCM treatment of diabetic foot. Computer retrieval of RCTs on TCM treatment of diabetic foot was performed in CNKI, Wanfang, SinoMed, PubMed, Cochrane Library, EMbase and Web of Science databases. Literature screening and data extraction were conducted independently by two researchers in strict accordance with inclusion and exclusion criteria. Any difference was resolved through discussion. A total of 72 RCTs involving 5 791 patients were included and 204 indicators were used. The number of indicators used in a single study was 2-22, with an average of 3 indicators used for each RCT. The indicators with top 16 frequency were clinical total effective rate, ankle brachial index(ABI), ulcer area, TCM syndrome integral, fibrinogen(FIB), fasting blood glucose(FBG), plasma viscosity(PV), c-reactive protein(CRP), saccharification blood of eggs(HbAlc), 2 h postprandial blood glucose(2 hPG), wound healing time, triglyce-rides(TC), TCM efficacy for syndromes, total cholesterol(TG), percutaneous oxygen partial pressure(TCPO2) and TCM symptom scores. The difference in selection of RCT indicators was large among TCM treatment methods for diabetic foot, and the combination of outcome indicators was arbitrary. The description on indexes was not standardized. Some non-laboratory examination indicators, some indicators not recommended in guidelines or not recognized in clinical practice, and some self-made indicators were not explained in detail. There was a lack of standardized evaluation criteria for indicators. The indicators had large time-point difference in measurement, and the time points were not distinguished in the measurement for diabetic foot patients with different degrees of severity. In addition, the patients with long course of treatment weren't timely measured. The characteristics of TCM or significant endpoint indicators were insufficient. It was urgent to establish the core index set of TCM in treating diabetic foot.

A comparative study of vancomycin loaded bone cement in the treatment of Wagner Ⅱ-Ⅳ diabetic foot / 中国骨伤

OBJECTIVE@#To investigate the clinical effect of vancomycin bone cement in the treatment of diabetic foot ulcer (DFU) ruptured Wagner gradeⅡ-Ⅳ.@*METHODS@#From March 2019 to April 2021, 32 patients with Wagner gradeⅡ-Ⅳ diabetic foot were divided into vacuum sealing drainage (VSD) group and bone cement group according to different treatment methods. There were 16 cases in VSD group, 8 males and 8 females;the age ranged from 66 to 81 (70.50±7.20) years, and the course of disease ranged from 8 to 40 (27.56±8.55) months;Wagner gradeⅡin 2 cases, grade Ⅲin 7 cases and grade Ⅳin 7 cases;debridement and VSD were used. There were 16 cases in the bone cement group, 9 males and 7 females;the age ranged from 63 to 79 (69.56±7.29) years, and the course of disease ranged from 11 to 39(22.75±11.43) months;Wagner gradeⅡ in 2 cases, grade Ⅲin 5 cases and grade Ⅳ in 9 cases;vancomycin loaded bone cement was used for treatment. The types of bacteria, negative time of bacterial culture, skin healing time, hospital stay, operation times and complications were observed and compared between two groups.@*RESULTS@#All patients were followed up for 3 to 6 (4.00±1.07) months. The bacterial negative time, skin healing time and hospital stay in bone cement group were significantly lower than those in VSD group (@*CONCLUSION@#Vancomycin loaded bone cement is effective in the treatment of Wagner grade Ⅱ-Ⅳ diabetic foot ulceration wounds. It can reduce the length of hospital stay, shorten the healing time of skin and kill pathogens as soon as possible. It is one of the effective methods to treat Wagner gradeⅡ-Ⅳdiabetic foot ulceration.

Microbiologic characteristics and antibiotic resistance rates of diabetic foot infections / Perfil microbiológico e de resistência bacteriana no pé diabético infectado

ABSTRACT Purpose: the purpose of this research was to identify the sociodemographic and microbiological characteristics and antibiotic resistance rates of patients with diabetic foot infections, hospitalized in an emergency reference center. Methods: it was an observational and transversal study. The sociodemographic data were collected by direct interview with the patients. During the surgical procedures, specimens of tissue of the infected foot lesions were biopsied to be cultured, and for bacterial resistance analysis. Results: the sample consisted of 105 patients. The majority of patierns were men, over 50 years of age, married and with low educational level. There was bacterial growth in 95 of the 105 tissue cultures. In each positive culture only one germ was isolated. There was a high prevalence of germs of the Enterobacteriaceae family (51,5%). Gram-negative germs were isolated in 60% of cultures and the most individually isolated germs were the Gram-positive cocci, Staphylococcus aureus (20%) and Enterococcus faecalis (17,9%). Regarding antibiotic resistance rates, a high frequency of Staphylococcus aureus resistant to methicillin (63,0%) and to ciprofloxacin (55,5%) was found; additionally, 43,5% of the Gram-negative isolated germs were resistant to ciprofloxacin. Conclusions: the majority of patients were men, over 50 years of age, married and with low educational level. The most prevalent isolated germs from the infected foot lesions were Gram-negative bacteria, resistant to ciprofloxacin, and the individually most isolated germ was the methicillin resistant Staphylococcus aureus.

RESUMO Objetivo: identificar o perfil sociodemográfico, microbiológico e de resistência bacteriana em pacientes com pé diabético infectado. Métodos: tratou-se de estudo observacional, transversal que avaliou os perfis sóciodemográfico e microbiológico de pacientes portadores de pé diabético infectado internados em Pronto Socorro de referência. Os dados sociodemográficos foram coletados por meio de entrevista. Foram colhidos, durante os procedimentos cirúrgicos, fragmentos de tecidos das lesões podais infectadas para realização de cultura/antibiograma. Resultados: a amostra foi composta por 105 pacientes. O perfil sociodemográfico mais prevalente foi o de pacientes do sexo masculino, acima dos 50 anos, casados e com baixa escolaridade. Das 105 amostras de fragmentos de tecidos colhidos para realização de cultura e antibiograma, 95 foram positivas, com crescimento de um único germe em cada um dos exames. Houve predomínio de germes da família Enterobacteriaceae (51,5%). Germes Gram-negativos foram isolados em 60,0% das culturas e os espécimes mais isolados individualmente foram os cocos Gram-positivos, Staphylococcus aureus (20,0%) e Enterococcus faecalis (17,9%). Considerando-se os perfis de resistência bacteriana, verificou-se alta taxa de Staphylococcus aureus resistente à meticilina (63,0%) e à ciprofloxacino (55,5%); verificou-se, também, que 43,5% dos germes Gram-negativos eram resistentes à ciprofloxacino. Conclusões: o perfil sociodemográfico majoritário, foi o de homens, com mais de 50 anos e com baixa escolaridade. Concluímos que os germes mais prevalentes nas lesões podais dos pacientes diabéticos foram os Gram-negativos, resistentes ao ciprofloxacino e que o germe mais isolado individualmente foi o Staphylococcus aureus resistente à meticilina.

Infecciones en pie diabético: Elección del tratamiento antibiótico empírico / Infections in diabetic foot. Choice of empirical antibiotic regimen

Las infecciones del pie diabético se asocian a complicaciones graves y constituyen la principal causa de hospitalización relacionada con diabetes y amputación de miembros inferiores. Para evitar su progresión, se requiere una conducta inicial rápida y adecuada que incluye toma de muestras para cultivos e inicio inmediato de tratamiento antibiótico empírico, según las características de las lesiones y la prevalencia local de microorganismos. Por ello, es necesario conocer y vigilar la microbiología local y la resistencia a los antimicrobianos. El objetivo de este trabajo fue describir la frecuencia de gérmenes en infecciones de pie diabético en pacientes ambulatorios asistidos en nuestro hospital en 2018 e identificar el esquema antibiótico con mayor cobertura, en comparación con los resultados de un estudio similar realizado en 2015. Fueron analizadas 72 muestras tomadas mediante punción por piel sana de partes blandas. Entre los 68 gérmenes aislados, los Gram negativos fueron los más frecuentes (47.1%), lo que representa un aumento significativo en relación a la frecuencia observada en 2015 (24.6%) p = 0.01 y un aumento de la sensibilidad a ciprofloxacina de 25% a 62.5% (p=0.03). El esquema con mayor cobertura fue amoxicilina-clavulánico con ciprofloxacina (77.9%) mientras que en 2015 fue amoxicilina-clavulánico con trimetoprima sulfametoxazol. La vigilancia de la microbiología local es fundamental para la elección del antibiótico empírico en las infecciones de pie diabético. En nuestro hospital, cuando la infección es de partes blandas, se recomienda la combinación amoxicilina-clavulánico más ciprofloxacina como esquema antibiótico empírico según los hallazgos de este estudio.

Diabetic foot infections are related to severe complications and constitute the main reason for diabetes-related hospitalization and lower limb amputations. A diabetic foot infection requires prompt actions to avoid progression of the infected wound; a soft tissue sample has to be taken for microbiological culture and empiric antibiotic therapy must be started immediately. Empiric antibiotic schemes should be chosen based on the severity of the infection and the local prevalence of microbial causal agents. Therefore, it is important to monitor these indicators. The aim of this study was to determine which microorganisms were more prevalent in cultures of diabetic foot infections during 2018 and what antibiotic combination was better to cover local microbiology, compared with data available from 2015 for a similar cohort. A total of 68 positive cultures were obtained of 72 soft tissue specimens analyzed. The most frequent microorganisms were Gram negative (47.1%), and resulted significantly more frequent than in 2015 (24.6%) p = 0.01. These Gram negative germs also resulted more sensitive to ciprofloxacin than in 2015 (62.5% vs. 25.0%) p = 0.03. Amoxicillin-clavulanate plus ciprofloxacin was the optimal combination therapy in 2018, while in 2015 it was amoxicillin-clavulanate plus trimethoprim sulfamethoxazole. In agreement with these results, we recommend amoxicillin-clavulanate plus ciprofloxacin as the empiric antibiotic regimen of choice for soft tissue infections in diabetic foot. We consider surveillance of local microbiology to be an important tool in the management of diabetic foot infections.

Evolución de las úlceras de pie diabético con el tratamiento mixto de Heberprot-P® y ozonoterapia / Evolution of diabetic foot ulcers with the mixed treatment of Heberprot-P® and ozone therapy

Introducción: El Heberprot-P® es un medicamento novedoso y único, prescrito para los pacientes con úlcera del pie diabético. El factor de crecimiento humano recombinante que contiene este fármaco induce el crecimiento de tejido de granulación útil. La ozonoterapia tiene propiedades como oxigenante, antioxidante, inmunomodulador, regenerador, antiinflamatorio y germicida y se utiliza para la desinfección de heridas desde la Primera Guerra Mundial. Objetivo: Determinar la evolución de las úlceras del pie diabético con el tratamiento mixto de Heberprot-P® y ozonoterapia. Métodos: Se realizó un estudio retrospectivo y descriptivo en todos los pacientes ingresados en el Instituto Nacional de Angiología y Cirugía Vascular con el diagnóstico de diabetes mellitus y úlcera de pie diabético que recibieron tratamiento mixto de Heberprot-P® y ozonoterapia. El período de estudio osciló de enero de 2016 hasta enero de 2017. Las variables estudiadas fueron: sexo, edad, tipo de diabetes, estadía hospitalaria, necesidad de ser reintervenido, tiempo de granulación y respuesta al tratamiento. Resultados: Se encontró que los pacientes tratados con el Heberprot-p® y ozonoterapia tuvieron una buena respuesta al tratamiento (60,5 por ciento), un tiempo de granulación entre 2 y 4 semanas (55,6 por ciento) con predominio de la estadía hospitalaria de 11 a 21 días. Conclusiones: Los pacientes con el tratamiento mixto de Heberprot-P® y ozonoterapia tienen una respuesta muy favorable(AU)

Introduction: Heberprot-P® is a novel and unique medication, prescribed for patients with diabetic foot ulcer. It is based on recombinant human growth factor that induces the growth of useful granulation tissue. The properties as oxygenating, antioxidant, immunomodulator, regenerator, anti-inflammatory and germicide of ozone therapy are used for the disinfection of wounds since the First World War. Objective: To determine the evolution of diabetic foot ulcers with the mixed treatment of Heberprot-P® and ozone therapy. Methods: A retrospective and descriptive study was conducted in all patients admitted to the National Institute of Angiology and Vascular Surgery (INACV) with the diagnosis of Diabetes Mellitus and diabetic foot ulcer who received mixed treatment of Heberprot-P® and ozone therapy. The study period ranged from January 2016 to January 2017. The studied variables were: sex, age, type of diabetes, hospital stay, need to be reoperated, granulation time and response to the treatment. Results: It was found that the highest percentage of patients who used the mixed treatment of Heberprot-P® and ozone therapy had a good response to treatment (60.5 percent) and a granulation time between 2 and 4 weeks (55.6 percent); and a hospital stay from 11 to 21 days. Conclusions: Patients with the mixed treatment of Heberprot-P® and ozone therapy have a very favorable response(AU)

Evaluación social del tratamiento con el Heberprot-p® en la asistencia primaria de salud / Social evaluation of Heberprot-p® treatment in primary health care

Introducción: En la actualidad Cuba mantiene implementado el Programa de Atención al Paciente con Úlcera de Pie Diabético con el uso del producto Heberprot-P® a nivel nacional. Objetivo: Revelar opiniones y comportamientos de los pacientes y profesionales inmersos en la aplicación del Heberprot-P® en pacientes. Métodos: Se presenta la fundamentación teórica metodológica del tema y los resultados de la evaluación con enfoque social realizada en la consulta primaria del policlínico "Julio Antonio Mella" de la Ciudad de Camagüey. Se realizaron encuestas a 19 pacientes para identificar necesidades sentidas a fin de cumplir su tratamiento; las actitudes en relación con el tratamiento a recibir y determinar el nivel de conocimiento de los factores de riesgo de su enfermedad, así como de la enfermedad en general. Además, entrevista en profundidad a personal médico y de enfermería que incluyó guía de observación in situ. Resultados: El trabajo permitió registrar opiniones favorables de los 19 pacientes investigados sobre la buena atención brindada por el médico y la enfermera de la consulta que aplicaron el Heberprot-P ®, así como la efectividad del fármaco para la mejoría de la enfermedad. También dos profesionales vinculados al servicio y un técnico ofrecieron criterios positivos en relación con esta asistencia médica. Conclusiones: Es importante mejorar la labor de captación de pacientes desde el nivel primario para garantizar un mayor alcance del Programa; la trascendencia del apoyo profesional en cada paciente, la excelente relación profesional de la salud-paciente y médico-enfermera, para obtener resultados satisfactorios en el tratamiento con Heberprot-P ®(AU)

Introduction: Cuba continues implementing nationwide the Diabetic Foot Ulcer Patient Care Program with the use of Heberprot-P®. Objective: To show the opinions and behaviours of patients and of Heberprot-P ® administration-related professionals. Methods: The theoretical-methodological substantiation as well as the results of the social approach-designed evaluation conducted in the primary health care office of Julio Antonio Mella polyclinics in the city of Camaguey were presented. The research took into account surveys of 19 patients to identify the needs they felt in order to finish their treatment, to know their attitudes towards the treatment to be received and to determine how much they knew about the risk factors of their pathology and their disease as a whole. Additionally, in-depth interviews were applied to the medical and nursing staff was also interviewed, including in- situ observation guide. Results: The research work allowed recording the positive opinions of the 19 surveyed patients about the proper care they received from the physician and the nurse who administered Heberprot-P® as well as the effectiveness of the product in the improvement of the disease. Two professionals and a technician related to the service expressed their positive criteria about this type of medical care. Conclusions: It is important to highlight the work carried out in selecting patients at the primary health care to assure wider scope of the program, the significance of the professional support given to every patient and the excellent health professional-patient and physician-nurse relationships in order to obtain satisfactory Heberprot-P® treatment results(AU)

Aplicación ambulatoria del Heberprot-p® en pacientes con pie diabético en el policlínico de Amancio / Ambulatory administration of Heberprot-p® to patients with diabetic foot in the polyclinics of Amancio municipality

Introducción: La úlcera de pie diabético es la complicación vascular más frecuente de la Diabetes Mellitus, asociada con un incremeto de los gastos económicos a los servicios de salud, a los paciente y a sus familiares, ya que es causa de amputación no traumática por lo que es considerada un problema de salud con un gran impacto económico y psico-social. Objetivo: Describir los resultados de la aplicación ambulatoria del Heberprot-P ®. a pacientes con pie diabético del Policlinico de Amancio Rodríguez. Métodos: Se llevó a cabo un estudio descriptivo de corte transversal en 43 pacientes del policlínico Luis Aldana Palomino, Amancio Rodríguez, provincia Las Tunas, con el diagnóstico de úlcera de pie diabético, a los cuales se les trató ambulatoriamente con Heberprot-P®. El período de estudio osciló de enero a diciembre de 2015. Resultados: los pacientes acudieron a la consulta con la úlcera en los grados I y II de la Clasificación Wagner, no se realizaron amputaciones mayores y el 90,7 por ciento logro cierre total. Conclusiones: La aplicación ambulatoria del Heberprot-P® en la atención primaria de salud mostró resultados satisfactorios re-incorporando a los pacientes a su vida social y laboral, sin limitaciones físicas, en un corto período de tiempo(AU)

Introduction: The diabetic foot ulcer is the most common vascular complication of diabetes mellitus and is associated to the rise of economic costs for the health service, for the patient and the family. It is the direct cause of non-trauma amputation and considered a health problem of high economic effect and great psychosocial impact. Objective: To describe the results of the ambulatory administration of Heberprot-P ® to patients with diabetic foot in the polyclinics of Amancio Rodriguez municipality. Methods: A descriptive, cross-sectional study of 43 patients seen at Luis Aldana Palomino polyclinic located in Amancio Rodríguez municipality, Las Tunas province. These patients were diagnosed with diabetic foot ulcer and treated at the outpatient service with Heberprot-P®. The study period ranged from January to December, 2015. Results: The patients presented with I and II grade ulcers according to Wagner classification when they were seen at the outpatient service; no major amputations were performed and 90.7 percent of cases reached total closure of their ulcers. Conclusions: The ambulatory administration of Heberprot-P® in the primary health care showed satisfactory results since the patients could go back to their regular social and working life in a short period of time, with no physical restrictions(AU)

Características del paciente con pie diabético no isquémico tratado con Heberprot-p® / Characterization of the patient with non-ischemic diabetic foot treated with Heberprot-P®

Introducción: La diabetes mellitus es una enfermedad que cada año aumenta su incidencia, así como sus complicaciones. El pie diabético es una de las más temidas debido a las características de la enfermedad y el daño vascular que presenta. El Heberprot-P® es un medicamento novedoso y único para el tratamiento de esta complicación, su uso oportuno es importante para salvar la extremidad. Objetivo: Describir las características de los pacientes con pie diabético no isquémico tratados con Heberprot-P®. Métodos: Se realizó un estudio descriptivo retrospectivo en 151 pacientes con pie diabético no isquémico tratados con Heberprot-P ® en el Hospital General Calixto García durante el 2013 y 2014. Las variables estudiadas fueron edad, sexo, tipo de diabetes, localización, reacciones adversas, características de la lesión y desenlace. Resultados: Se encontró que el 49,7 por ciento de los pacientes eran mayores de 60 años el 59,6 por ciento hombres y el 92 por ciento padecía de diabetes mellitus de tipo 2. La localización de la lesión fue más frecuente en los dedos de los pies (33,8 por ciento). El 21,1 por ciento tuvo alguna reacción adversa donde la más frecuente fueron los escalofríos. Los grados de Wagner que más casos presentaron fueron el 2 (31,1 por ciento) y el 3 (32,4 por ciento); las lesiones cicatrizaron en el 84,1 por ciento y se amputó el 2,6 por ciento del total de pacientes. Conclusiones: Se observó que los hombres diabéticos de tipo 2, mayores de 60 años son los más propensos a padecer la enfermedad, presentan pocas reacciones adversas, elevada frecuencia de curación y pocas amputaciones(AU)

Introduction: Diabetes mellitus is a disease whose incidence and complications annually increase. Diabetic foot is one of the most fearful complications due to its characteristics and the vascular damage that occurs. The Heberprot-P is a novel and unique drug for the treatment of this complication. Timely and appropriate use is important for limb salvage.nObjective: To describe the characteristics of patients with non ischemic diabetic foot treated with Heberprot-P. Methods: Retrospective, descriptive and observational study conducted in 151 patients with non-ischemic diabetic foot treated with Heberprot-P ® in General Calixto García hospital in 2013 and 2014. The collected variables were age, sex, location, side effects, injury characteristics and outcomes. Results: We found that 49.6 percent of patients were over 60 years of age, 59.6 percent were men and 92 percent who suffered from type 2 diabetes mellitus. The most frequent location was the toes (33.8 percent). In the study group, 21.1 percent had some adverse reaction, being chills the most frequent. The highest number of cases went to Wagner classification II (31.1 percent) and III (32.4 percent); the lesions healed in 84.1 percent of patients whereas 2.6 percent were amputated. Conclusions: It was observed that type 2 diabetic men aged over 60 years were more likely to suffering the disease, to having few adverse reactions, to healing more frequently and to being less amputated(AU)

Características de los diabéticos tratados con Heberprot-p® en el municipio de Colón / Characteristics of the diabetics treated with Heberprot-p® in Colón municipality

Introducción: Una de las complicaciones vasculares más devastadora de la diabetes mellitus lo constituye el pie diabético y participan en su aparición y desarrollo, la neuropatía, la isquemia y la infección. Objetivo: Caracterizar a los pacientes diabéticos tratados con Heberprot-p®. Métodos: Estudio descriptivo-retrospectivo en 213 pacientes con úlceras de pie diabético en el municipio de Colón, provincia de Matanzas, en el período comprendido entre enero de 2013 a diciembre de 2015. Se analizaron las siguientes variables: edad, sexo, control metabólico, años de evolución de la enfermedad, factores de riesgo, grados de la clasificación de Wagner, tiempo de epitelización y número de amputaciones realizadas en el período de estudio. Se calcularon las frecuencias absolutas y relativas. Resultados: Se encontró un predominio de los mayores de 60 años (38,5 por ciento); del sexo femenino (n= 1 09; 51,2 por ciento) y de pacientes con más de 10 años de evolución (n= 120; 56,3 por ciento). Se constató que el 53,5 por ciento tenían un control metabólico adecuado. El 25,8 por ciento tenían, como factor de riesgo, un aumento de la presión plantar. Predominaron los grado 1 y 3 de la clasificación de Wagner. El 72,8 por ciento logró una epitelización completa en menos de 40 días y el 12,2 por ciento fue amputado. Conclusión: La aplicación del Heberprot-p® en el tratamiento de las úlceras de pie diabético redujo el tiempo de epitelización y el número de amputaciones de los miembros inferiores en los diabéticos del municipio de Colón(AU)

Introduction: One of the most devastating vascular complications of Diabetes Mellitus is the diabetic foot, and development, neuropathy, ischemia and infection are usually involved in its onset and development. Objective: To characterize diabetic patients treated with Heberprot-P ®. Methods: A descriptive and retrospective study was conducted in 213 patients with diabetic foot ulcers in Colón municipality, Matanzas province, in the period of January 2013 through December 2015. The following variables were analyzed: age, sex, metabolic control, years of progression of the disease, risk factors, Wagner classification, time of epithelization and number of amputations performed in the study period. Absolute and relative frequencies were calculated. Results: Patients older than 60 years (38.5 percent); women (n=109; 51.2 percent) and patients with more than 10 years having the disease (n = 120; 56.3 percent) predominated in the study. It was found that 53.5 percent had adequate metabolic control. The risk factor in 25.8 percent was foot pressure increase. Wagner´s classification I and II prevailed. In the group, 72.8 percent reached complete epithelization in less than 40 days and 1.2 percent underwent amputation(AU)

Costo-beneficio del tratamiento con Heberprot-P® en pacientes con pie diabético / Cost-benefit of the treatment with Heberprot-P® in patients with diabetic foot

Se realizó un estudio descriptivo y transversal de 56 pacientes con diabetes mellitus, a quienes se le diagnosticó pie diabético, pertenecientes al área de salud del Policlínico Universitario Josué País García de Santiago de Cuba, desde enero hasta diciembre del 2016, a fin de determinar el costo-beneficio del tratamiento con Heberprot-P®. La aplicación de dicho tratamiento resultó beneficiosa, pues se logró la curación de todos los pacientes. Se concluyó que, a pesar del costo elevado que representa la aplicación del novedoso tratamiento, constituyó un beneficio significativo para los afectados, puesto que se evitó la aplicación de técnicas quirúrgicas costosas y las amputaciones; además, favoreció una mejor calidad de vida, se extendió la vida socialmente útil, disminuyeron los problemas desde el punto de vista social y una alta erogación de gastos en asistencia social

A descriptive and cross-sectional study of 56 patients with diabetes mellitus to whom diabetic foot was diagnosed, belonging to the health area of Josué País García University Polyclinic in Santiago de Cuba was carried out from January to December, 2016, in order to determine the cost-benefit of the treatment with Heberprot-P®. This treatment was beneficial, because the cure of all patients was achieved. It is concluded that, in spite of the high cost that represents the administration of the novel treatment, it constituted a significant benefit for those affected, since the use of expensive surgical techniques and the amputations were avoided; also, it favored a better life quality, the socially useful life was expanded, the problems decreased from the social point of view as well as the high expenditure of expenses in social care

Efectividad de una nueva propuesta en el tratamiento antimicrobiano de la infección del pie diabético / Effectiveness of a new proposal for antibiotic treatment of the diabetic foot infection

Introducción: Las úlceras del pie diabético son asiento de infecciones que pueden poner en peligro tanto la extremidad como la vida del paciente. Su adecuado diagnóstico es necesario para efectuar un tratamiento antimicrobiano apropiado. Objetivo: Evaluar la correlación entre el uso de un nuevo protocolo de antibiótico-terapia y la respuesta favorable de las infecciones del pie diabético, según procederes quirúrgicos y tiempo de estadía hospitalaria. Métodos: Se realizó un estudio experimental en el Hospital Provincial "Dr. Antonio Luaces Iraola", de Ciego de Ávila desde octubre de 2012 a septiembre de 2015. La muestra de 100 pacientes obtenida de forma aleatoria se dividió en dos grupos, uno control, al cual se le aplicó el esquema propuesto en el Programa de Atención Integral al paciente con ulcera de pie diabético, y otro experimental, al que se le aplicó un esquema basado en el mapa microbiológico local. Se caracterizó la muestra según edad, sexo, tiempo de evolución como diabético, clasificación según Wagner, y severidad de la infección. Se aplicaron las pruebas chi cuadrado, t de Student y de U de Mann-Whitney para demostrar igualdad entre los grupos. Resultados: Los procederes quirúrgicos requeridos en el grupo control, resultaron significativamente más invasivos que en el grupo experimental; y los pacientes del primero precisaron de más días de ingreso hospitalario que los del segundo. Conclusiones: La aplicación de un esquema antimicrobiano basado en las características microbiológicas locales propicia la realización de menos amputaciones y se acorta la estadía hospitalaria de los pacientes tratados por pie diabético(AU)

Introduction: The diabetic foot ulcers are common locations for serious infections that can affect both the limb and the patient´s life. Early appropriate diagnosis is necessary to establish a correct antibiotic treatment. Objective: To assess the correlation between the use of a new protocol for antibiotic treatment and the favorable response of the diabetic foot infections, depending on surgical procedures and length of stay at hospital. Methods: An experimental study has been conducted in "Dr. Antonio Luaces Iraola" hospital in Ciego de Ávila province from October 2012 to September 2015. A random sample of 100 patients was divided into two groups, one was treated with the comprehensive care program for patients with diabetic foot ulcers and the other with the new proposed protocol based on the local microbiological map. The sample was characterized by age, gender, length of time with diabetes, Wagner classification and severity of infection. Chi square, T student and U Mann-Whitney tests were applied to prove equality between groups. Results: Surgical procedures needed in the control group were more invasive than in the experimental group and patients from the former group had a longer stay at hospital than the latter. Conclusions: The use of an antibiotic protocol based on the local microbiological characteristics favor the reduction of the number of amputations and shorter stay at hospital in patients with diabetic foot(AU)

Resultados y reacciones adversas en pacientes tratados con Heberprot-P® en la comunidad / Results and adverse reactions observed in patients treated with Heberprot-P in the community setting

Introducción: La diabetes mellitus es considerada una epidemia en estos momentos a nivel mundial. Al aumentar la prevalencia de esta enfermedad aumenta la de pie diabético con sus respectivas lesiones. Objetivos: Determinar los resultados y reacciones adversas en pacientes tratados Heberprot-P® en la comunidad. Método: Estudio prospectivo en 17 pacientes con distintas lesiones de pie diabético atendidos en un área de salud entre enero de 2012 y abril de 2013. A todos se les aplicó, de forma ambulatoria, Heberprot-P® (factor de crecimiento epidérmico recombinante humano) hasta la granulación total de las lesiones. Resultados: El 52,94 por ciento de los pacientes tenían pie diabético grado 4 según la clasificación de Wagner. El 100 por ciento de los enfermos mostraron resultados satisfactorios. Las reacciones adversas se presentaron en seis ocasiones y en tres pacientes. Conclusiones: Se alcanzaron buenos resultados con el uso del Heberprot-P® considerados por las pocas reacciones adversas y la ausencia de amputación sobre todo en los pacientes diabéticos con úlceras del pie grado 4 de Wagner. El Heberprot-P® constituye un medicamento a tener en cuenta en la curación de las úlceras del pie diabético con la ventaja de que puede utilizarse de forma ambulatoria(AU)

Introduction: Diabetes mellitus is currently considered as an epidemic worldwide. With the rise of the prevalence of this disease, that of the diabetic foot with its different lesions increases too. Objectives: To determine the results and the adverse reactions in patients treated with Heberprot-P® in the community setting. Method: Prospective study of 17 patients with various diabetic foot lesions, who were seen in a health area from January 2012 to April 2013. They all received an outpatient treatment with Heberprot-P® (human recombinant epidermal growth factor) until complete granulation of lesions. Results: In the group, 52.94 percent of patients had grade 4 diabetic feet according to Wagner´s classification scale. All the treated patients showed satisfactory results and adverse reactions occurred six times in three patients. Conclusions: Good results are achieved with the use of Heberprot-P® due to few adverse reactions and absence of amputation, mainly in diabetics with grade 4-foot ulcers in Wagner´s classification scale. This is a drug to be taken into consideration for curing diabetic foot ulcers since it can also be used in outpatient treatment(AU)

Respuesta al tratamiento con Heberprot-P® según la severidad de la enfermedad arterial periférica / Response to treatment with Heberprot-P® depending on the severity of the peripheral arterial disease

Introducción: El pie diabético es uno de los problemas más grave en la medicina contemporánea que aún no se ha resuelto. Actualmente el Heberprot-P ® constituye una alternativa terapéutica para su solución. Objetivos: Identificar en los pacientes con úlcera de pie diabético el grado de severidad de la enfermedad arterial periférica en función del índice tobillo/brazo y determinar la respuesta al tratamiento con Heberprot-P® según el grado de severidad de la enfermedad arterial periférica. Métodos: Estudio retrospectivo, descriptivo de corte transversal en 156 pacientes diabéticos ingresados entre junio de 2010 a diciembre de 2011 en el Instituto Nacional de Angiología y Cirugía Vascular por presentar una úlcera de pie diabético y recibieron tratamiento con Heberprot-P ®. Las variables estudiadas fueron: sexo, edad, tipo de diabetes y tiempo de evolución de la misma, grado de severidad de la enfermedad arterial periférica según los valores del índice tobillo-brazo, y el porcentaje de granulación a las ocho semanas de tratamiento. Resultados: Se observó una mayor proporción de pacientes con un grado de severidad normal los cuales tuvieron el 92,8 por ciento de respuesta al tratamiento. El 33,3 por ciento de no respuesta presentaba un grado severo de enfermedad arterial periférica. Conclusión: Los pacientes con un grado severo de enfermedad arterial periférica o valores bajos del índice de presiones tobillo-brazo no tienen una respuesta favorable a la administración del Heberprot-P®(AU)

Introduction: Heberprot-P® presently represents a therapeutic alternative for this illness. Objective: To determine the response to Heberprot-P ® treatment in patients with diabetic foot ulcers, depending on the level of severity of the peripheral arterial disease. Methods: Retrospective, descriptive and cross-sectional study of 156 patients with diabetic foot ulcers, who were admitted to the National Institute of Angiology and Vascular Surgery from June 2010 through December 2011. They were treated with Heberprot-P ® during hospitalization. The studied variables were sex, age, type of diabetes and time of progression, level of severity of the peripheral arterial disease according to the ankle-brachial pressure indexes, and the percentage of granulation after eight-week treatment. Results: The proportion of patients with normal level of disease was higher, 92.8 percent of whom positively responded to treatment whereas 7.2 percent did not. Among the patients with severe peripheral arterial disease, 33.3 percent showed no response to this treatment. Conclusion: The patients with severe peripheral arterial disease or low ankle-brachial pressure index do not show favorable response to the administration of Heberprot-P®(AU)