Risk factors for plantar foot ulcer recurrence in patients with diabetes - A prospective pilot study.

INTRODUCTION: Diabetic foot ulcer (DFU) is a complication of diabetes mellitus (DM) with established recurrence risk factors evaluating patients from United States or Europe. There are scarce studies in developing countries about these risks. The aim of this study was to evaluate risk factors associated with DFU recurrence in a Brazilian prospective cohort. MATERIALS AND METHODS: A prospective cohort of patients with healed DFU followed from January 2014 to June 2017 in Curitiba, Brazil. Periodic home visits from a specialist nurse in DFU were performed during the period of the study to evaluate recurrence of ulcer. The presence of risk factors in the group of patients that developed an ulcer in the follow-up period was compared with the presence of these factors in the group of patients without recurrence. At enrollment, 35 subjects presented a previous ulcer distal with complete healing to follow-up. RESULTS: From 35 patients, 15 were male (43%) and the mean age was of 65.8 ± 10.9 years (48-85 year). Most patients were married with a low income (

Cicatrização de úlceras por pressão com extrato Plenusdermax® de Calendula officinalis L / Cicatrización de úlceras por presión con extracto de Plenusdermax® Calendula officinalis L / Pressure ulcer healing with Plenusdermax® Calendula officinalis L extract

RESUMO Objetivo: Avaliar os benefícios terapêuticos do extrato de bioativos de Calendula officinalis Plenusdermax® na cicatrização de úlceras de pressão. Métodos: estudo observacional de coorte realizado com quarenta e um pacientes com diagnóstico de úlcera por pressão com tamanho da ferida estável por mais de três meses. Os pacientes foram avaliados quinzenalmente durante 30 semanas, em relação a redução da área da lesão, controle de infecção, tipos de tecido e exsudato e microbiologia das úlceras. Resultados: a proporção de pacientes que cicatrizaram completamente após 15 e 30 semanas de tratamento foi 63% e 88%, respectivamente, sendo que a média de tempo de cicatrização foi de 12,5 ± 7,8 semanas. Não foram observados eventos adversos durante o tratamento. Conclusão: os resultados do estudo indicam que Plenusdermax® de bioativos de C. officinalis é um tratamento seguro que promove a cicatrização de úlceras de pressão.

RESUMEN Objetivo: evaluar los beneficios terapéuticos del extracto bioactivo de Calendula officinalis Plenusdermax® en la cicatrización de úlceras por presión. Método: estudio observacional de cohorte con cuarenta y un pacientes con diagnóstico de úlceras por presión con un tamaño de herida estable durante más de tres meses. Se evaluó a los pacientes durante 30 semanas cada dos semanas, incluyendo reducción del área de lesión, control de infecciones, tipos de tejidos y secreciones y microbiología de las úlceras. Resultados: la proporción de pacientes con cicatrización completa después de 15 y 30 semanas de tratamiento fue de 63% y 88%, respectivamente, y el promedio de todos los tiempos de cicatrización fue de 12.5±7.8 semanas. No se observaron eventos adversos durante el tratamiento. Conclusión: los resultados del estudio indican que Plenusdermax® con bioactivos de C. officinalis es un tratamiento seguro que promueve la cicatrización de úlceras por presión.

ABSTRACT Objective: to evaluate the therapeutic benefits of the bioactive extracts of Plenusdermax®Calendula officinalis for pressure ulcer healing. Method: an observational cohort study, including 41 patients with a diagnosis of pressure ulcer that was stable in size for more than three months. Patients were evaluated every two weeks, over 30 weeks, for: reduction of the wound area, infection control, types of tissue and exudate, and ulcer microbiology. Results: the proportions of patients who were completely healed after 15 and 30 weeks of treatment were 63% and 88%, respectively, and the mean healing time was 12.5±7.8 weeks. No adverse events were observed during treatment. Conclusion: the results of the study indicate that bioactive C. officinalis Plenusdermax® is a safe treatment that promotes healing of pressure ulcers.

A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg/dL (range 82-395 mg/dL), most (34) with Wagner type 1 ulcers--completed the study. The proportions of patients who achieved complete wound closure after 11, 20, and 30 weeks of treatment was 54%, 68%, and 78%, respectively; mean healing time was 15.5 ± 6.7 weeks. When individual weekly healing rates (the percentage reduction in wound area per week) were corrected for variability in initial DFU area, the values were nearly 6-fold higher for complete wound closure (7.8% ± 3.6%) than for incomplete wound closure (1.4% ± 0.7%) (Student t-test; P = 0.001). After 30 weeks of treatment, the number of colonized wounds decreased from 29 at baseline to 5, and the number of odorous wounds decreased from 19 to 1. Ulcer bed planimetry data showed a significant reduction in the amount of exudate, fibrin slough, and necrotic tissue after the treatment with C. officinalis hydroglycolic extract (χ(2) test; P = 0.001). No adverse events were observed during treatment. The study findings suggest C. officinalis extract is safe and has a beneficial effect on DFU healing. Randomized, controlled studies using C. officinalis hydroglycolic extract are warranted to confirm its safety and establish its clinical efficacy and effectiveness for the topical treatment of DFUs.