Tolerability and safety of conventional therapy combination with DeMarco formula for infected ischemic diabetic foot.

BACKGROUND: A study has found that major amputations are necessary on 69% of ischemic diabetic foot patients treated with conventional therapy. An uncontrolled study of 31 patients showed that only 33% needed major amputation after treatment with conventional therapy plus De Marco Formula (DMF), a novel formulation of procaine and Polyvinylpyrrolidone. OBJECTIVE: To assess the tolerability and safety of the combination of conventional therapy and De Marco Formula for infected ischemic diabetic foot. METHODS: Adult patients, 10 male/24 female, were treated with the conventional therapy for diabetic foot plus DMF (0.15 ml/kg/day IM) during ten days and then twice a week until healing of the lesions or completion of a 52-day period. Required amputations, lesion areas, adverse events occurrence and clinical laboratory parameters (hemoglobin, blood cell counts, glycosilated hemoglobin, total proteins, creatinine, alanine transaminase and alkaline phosphatase) were determined during the treatment period. RESULTS: Two slight (5.88%) and one moderate (2.94%) adverse events (mainly cutaneous rash) were reported. The last one was reported on the 15th day of treatment and DMF dosing was discontinued by patient's request. Clinical laboratory mean values remained within normal ranges during treatment except for blood leukocyte counts that pathologically elevated at baseline and decreased to normality by treatment end. This study has found that 18.08% of patients (N=6) needed a lower limb amputation with the combined treatments. The standard reported rate in Cuba is 25-29%. Furthermore, a progressive reduction of the mean lesion area from 51.29 cm2 at the beginning to 1.89 cm2 at the end of the treatment (p=0.000001) was observed. CONCLUSION: The treatment with De Marco Formula for 52 days as an adjuvant for the conventional therapy for infected ischemic diabetic foot was well tolerated and safe. These findings are consistent with those of a randomized prospective controlled study performed later.

[Association between test results for HIV/AIDS screening and sex. Esmeraldas-Ecuador, 2016]. / Asociación entre resultados de pruebas para tamizar VIH y el sexo. Esmeraldas, Ecuador. 2016.

OBJECTIVE: A descriptive, correlational, retrospective cross-sectional study was carried out to determine if there was any dependence between sex and the results of HIV/AIDS screening tests in the 08D01 district of the city of Esmeraldas, Ecuador, for the period covered January-December 2016. MATERIALS AND METHODS: 100% of the people who were screened for HIV/AIDS were included in the study. Central tendency measures such as mean, rank and percentage were used, as well as Chi square tests to determine dependence between both variables. CONCLUSIONS: There is a higher prevalence in men than in women, reaching a ratio of one woman infected with HIV/AIDS for every 1.2 men, as well as a tendency to have a significant increase of reactive results in males and a decrease of reactive results in the female sex when performing the test.

OBJETIVO: Se realizó un estudio descriptivo, transversal retrospectivo, análisis de fuentes secundarias con el objetivo de determinar si existía dependencia entre el sexo y los resultados en las pruebas de tamizaje para VIH/Sida, en el distrito 08D01, ciudad de Esmeraldas en el período comprendido de enero a diciembre de 2016. MÉTODOS: Se estudió el 100% de las personas que fueron tamizadas para VIH/Sida por lo que no fue necesario el cálculo de muestra. Se utilizaron frecuencias absolutas y porcentaje, y estadígrafos distribuidos Chi cuadrado para determinar dependencia entre dos variables cualitativas. CONCLUSIONES: Se concluyó la existencia de una prevalencia de hombres más elevada que en mujeres, la razón fue de una mujer infectada de VIH/Sida por cada 1,2 hombres. Se realizaron más pruebas en mujeres (95%) que en hombres.

Asociación entre resultados de pruebas para tamizar VIH y el sexo: Esmeraldas, Ecuador. 2016 / Association between test results for HIV/AIDS screening and sex: Esmeraldas-Ecuador, 2016

RESUMEN Objetivo Se realizó un estudio descriptivo, transversal retrospectivo, análisis de fuentes secundarias con el objetivo de determinar si existía dependencia entre el sexo y los resultados en las pruebas de tamizaje para VIH/Sida, en el distrito 08D01, ciudad de Esmeraldas en el período comprendido de enero a diciembre de 2016. Métodos Se estudió el 100% de las personas que fueron tamizadas para VIH/Sida por lo que no fue necesario el cálculo de muestra. Se utilizaron frecuencias absolutas y porcentaje, y estadígrafos distribuidos Chi cuadrado para determinar dependencia entre dos variables cualitativas. Conclusiones Se concluyó la existencia de una prevalencia de hombres más elevada que en mujeres, la razón fue de una mujer infectada de VIH/Sida por cada 1,2 hombres. Se realizaron más pruebas en mujeres (95%) que en hombres.(AU)

ABSTRACT Objective A descriptive, correlational, retrospective cross-sectional study was carried out to determine if there was any dependence between sex and the results of HIV/AIDS screening tests in the 08D01 district of the city of Esmeraldas, Ecuador, for the period covered January-December 2016. Materials and Methods 100% of the people who were screened for HIV/AIDS were included in the study. Central tendency measures such as mean, rank and percentage were used, as well as Chi square tests to determine dependence between both variables. Conclusions There is a higher prevalence in men than in women, reaching a ratio of one woman infected with HIV/AIDS for every 1.2 men, as well as a tendency to have a significant increase of reactive results in males and a decrease of reactive results in the female sex when performing the test.(AU)

Clinical evaluation of De Marco formula as an adjunctive therapy for infected ischemic diabetic foot: a prospective randomized controlled trial.

BACKGROUND: De Marco Formula (DMF) is a novel formulation of procaine and PVP. OBJECTIVE: To assess the efficacy and safety of DMF as an adjunctive therapy for infected ischemic diabetic foot in a prospective randomized controlled clinical trial. METHODS: Adult patients, 39 male/ 79 female, were randomly assigned (59 patients/treatment group) to the conventional therapy alone (A) or plus DMF (0, 15 ml/kg .day i.m.) during ten days and them twice a week until healing of the lesions or completion of 52 days (B).The response to the treatment was considered favorable when an amputation was not needed even though a decrease of the wound area or complete healing was not shown. It was considered unfavorable when a major amputation was necessary because of worsening of the lesion (wound spreading to any magnitude greater than the initial one) or the appearance of new wounds in the same leg. RESULTS: Both groups were comparable with regard to age, sex, level of arterial occlusion, type of lesion, anatomic localization of lesions and previous surgical procedures. The cumulative percentage of unfavorable results was significantly lower after treatment B with respect to treatment A (25.4% vs. 45.8%; p= 0.02), for a reduction of 44.5%. Four slight adverse reactions were associated with DMF: vertigo and nausea at the 7th treatment administration (one patient), and headache and tachycardia at the 12th dose (another patient). Blood hemoglobin and leukocyte counts and serum alanine transaminase were not affected. CONCLUSION: The treatment with DMF for 52 days as an adjuvant for the conventional therapy was associated with a lower need for major amputations. It was also well tolerated and safe.