Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial.

Chronic wounds, especially those that are hard-to-heal, constitute a serious public-health problem. Although progress has been made in the development of wound dressings for healing, there is little high-quality evidence of their efficacy, with no evidence of superiority in the use of one hydrogel over another. To evaluate the superiority of a hydrogel (EHO-85), containing Olea europaea leaf extract (OELE), over a standard hydrogel (SH), the promotion and/or improvement of healing of difficult-to-heal wounds was compared in a prospective, parallel-group multicenter, randomized, observer-blinded, controlled trial ("MACAON"). Non-hospitalized patients with pressure, venous or diabetic foot-ulcers difficult-to-heal were recruited and treated with standard care, and EHO-85 (n = 35) or VariHesive (n = 34) as SH. Wound-area reduction (WAR; percentage) and healing rate (HR; mm2/day) were measured. EHO-85 showed a statistically significant superior effect over VariHesive. At the end of the follow-up period, the relative WAR decreased by 51.6% vs. 18.9% (p < 0.001), with a HR mean of 10.5 ± 5.7 vs. 1.0 ± 7.5 mm2/day (p = 0.036). EHO-85 superiority is probably based on its optimal ability to balance the ulcer bed, by modulating pH and oxidative stress. That complements the wetting and barrier functions, characteristics of conventional hydrogels. These results support the use of EHO-85 dressing, for treatment of hard-to-heal ulcers. Trial Registration AEMPS:PS/CR623/17/CE.

EHO-85, Novel Amorphous Antioxidant Hydrogel, Containing Olea europaea Leaf Extract-Rheological Properties, and Superiority over a Standard Hydrogel in Accelerating Early Wound Healing: A Randomized Controlled Trial.

Many advanced wound healing dressings exist, but there is little high-quality evidence to support them. To determine the performance of a novel amorphous hydrogel (EHO-85) in relation to its application, we compared its rheological properties with those of other standard hydrogels (SH), and we assessed the induction of acceleration of the early stages of wound healing as a secondary objective of a prospective, multicenter, randomized, observer-blinded, controlled trial. The patients were recruited if they had pressure, venous, or diabetic foot ulcers and were treated with EHO-85 (n = 103) or VariHesive® (SH) (n = 92), and their response was assessed by intention-to-treat as wound area reduction (WAR (%)) and healing rate (HR mm2/day) in the second and fourth weeks of treatment. Results: EHO-85 had the highest shear thinning and G'/G″ ratio, the lowest viscous modulus, G″, and relatively low cohesive energy; EHO-85 had a significantly superior effect over SH in WAR and HR, accelerating wound healing in the second and fourth weeks of application (p: 0.002). This superiority is likely based on its optimal moisturizing capacity and excellent pH-lowering and antioxidant properties. In addition, the distinct shear thinning of EHO-85 facilitates spreading by gentle hand pressure, making it easier to apply to wounds. These rheological properties contribute to its improved performance.

Superiority of a Novel Multifunctional Amorphous Hydrogel Containing Olea europaea Leaf Extract (EHO-85) for the Treatment of Skin Ulcers: A Randomized, Active-Controlled Clinical Trial.

This 8-week, multicenter, randomized, active-controlled, observer-blinded clinical trial was designed to demonstrate the accelerating effect on wound healing of the novel Olea europaea leaf extract hydrogel (EHO-85) by comparing it to a widely used amorphous hydrogel. Results showed that EHO-85 significantly accelerated wound healing, regardless of ulcer etiology (pressure, venous leg or diabetic foot) and prognosis, doubling the median wound area reduction compared with a reference amorphous hydrogel (79.4% vs. 39.7%; difference: −39.7%, 95% CI: −71.1 to −21.3%; p < 0.001). The intention-to-treat analysis was conducted on 195 patients from 23 Spanish health centers/nursing homes. This novel treatment balances the ulcer microenvironment by modulating reactive oxygen species and pH. These actions complement the moistening and barrier functions inherent to amorphous hydrogels, whilst also conferring EHO-85 its documented granulation formation and pain relief properties. Furthermore, efficacy was achieved safely and in a cost-efficient manner due to its multi-dose format, which reduced the amount of product needed by 85.8% over 8 weeks compared to single-use hydrogel. The present randomized controlled trial is a relevant milestone in evidence-based practice for being the first to demonstrate (i) the effectiveness of an amorphous hydrogel in accelerating wound healing and (ii) the superiority of a specific hydrogel over another.

[Effectiveness and efficacy of self-measurement of capillary blood glucose in patients with type 2 diabetes mellitus]. / Efectividad y eficacia del autoanálisis de la glucemia capilar en pacientes con diabetes tipo 2.

BACKGROUND AND OBJECTIVE: The efficacy of self-measurement of capillary blood glucose (SMBG) in patients with type 2 diabetes mellitus is not fully established. The objectives of the study were: a) to verify the efficacy of the SMBG in patients with type 2 diabetes mellitus in the primary care set; b) to investigate the possible causes that explain the lack of effectiveness of the method, in their case, and c) to deduce the predictive variables that permit to select good utilizador of the SMBG. PATIENTS AND METHOD: Clinical trial controlled and randomized carried out in the environment of the primary care, on type 2 diabetic patients. The patients were assigned, of random form and stratified, according to the type of treatment for diabetes that received, in 2 groups: SMBG group (SMBG-G) and control group (CG). The period of monitoring was of 12 months. The efficacy of the SMBG was analyzed, and also its effectiveness. RESULTS: 100 patients were included in the study. Out of them, 51 were assigned to SMBG-G and 49 to CG. The SMBG was efficient in the 21.6% of SMBG-G and in 14.3% patients of the CG (p = 0.44). The SMBG efficacy was greater in patients with combined treatment and in those who received only insulin (50% in both cases). No improvement was observed in patients on treatment with diet (p = 0.006). The effectiveness for the cut off from value the HbA1c was of 59.2% and of 29.58% for the totality of the European criteria of metabolic control. The independent predictor variables of the SMBG efficacy were: the evolution years number of the diabetes mellitus and a deficient control of the illness at the start of the study. The global precision of the mathematical model obtained was of 88.24% with sensibility of 54.5%, especificity of 97.5%, positive predictor value of 85.7% and negative predictive value of 11.4% (p < 0.001). The area under the ROC curve was of 89.9% (p < 0.001) (95% confidence interval, 81.2-98.5%). According to the ROC curve, the point of cut that better the SMBG efficacy discriminated was that of 74% (sensibility: 72.7%; especificity: 77.5%). CONCLUSIONS: SMBG is a tool that, although can improve the metabolic control of type 2 diabetes, requires a careful selection of patients and, therefore, cannot be utilized in an indiscriminate way. The time of evolution of the illness and fundamentally, the presence of a deficient metabolic control of the disease should be the factors that determine a good selection. Therefore, its extended use among the type 2 diabetic population, without a prior selection, does not seem to be justified.

Efectividad y eficacia del autoanálisis de la glucemia capilar en pacientes con diabetes tipo 2 / Effectiveness and efficacy of self-measurement of capillary blood glucose in patients with type 2 diabetes mellitus

Fundamento y objetivo: La eficacia del autoanálisis (AA) de la glucemia capilar en los pacientes con diabetes tipo 2 no está plenamente establecida. Los objetivos del presente estudio han sido: a) comprobar la eficacia del AA en pacientes con diabetes mellitus tipo 2 en el ámbito de la atención primaria; b) indagar las posibles causas que expliquen la falta de efectividad del método, en su caso, y c) deducir los factores predictivos que permitan seleccionar al buen utilizador del AA. Pacientes y método: Se trata de un ensayo clínico controlado y aleatorizado realizado en el ámbito de la atención primaria, en pacientes con diabetes mellitus tipo 2. Éstos se asignaron, de forma aleatoria y estratificada, según el tipo de tratamiento antidiabético que recibían, en 2 grupos: grupo de autoanálisis (GAA) y grupo control (GC). El período de seguimiento fue de 12 meses. Se analizaron la eficacia del AA y su efectividad. Resultados: De los 100 pacientes incluidos en el estudio, 51 fueron asignados al GAA y 49 al GC. El AA fue eficaz en el 21,6% de los pacientes del GAA frente al 14,3% en el GC (p = 0,44). La eficacia del AA fue mayor en los grupos de pacientes con tratamiento combinado y con tratamiento exclusivamente insulínico (un 50% en ambos casos), sin observarse mejoría en el grupo de tratamiento exclusivo con dieta (p = 0,006). La efectividad para el valor aislado de la hemoglobina glucosilada fue del 59,2%, y del 29,58% para la totalidad de los criterios europeos de control metabólico. Las variables predictoras independientes de la eficacia del AA fueron el número de años de evolución de la diabetes mellitus y un control deficiente de la enfermedad al inicio del estudio. La precisión global del modelo matemático obtenido fue del 88,24%, con una sensibilidad del 54,5%, especificidad del 97,5%, valor predictivo positivo del 85,7% y valor predictivo negativo del 11,4% (p < 0,001). El área bajo la curva de eficacia diagnóstica fue del 89,9% (p < 0,001) (intervalo de confianza del 95%, 81,2-98,5%). El punto de corte que, según la curva de eficacia diagnóstica, mejor discriminó la eficacia del AA fue el 74% (sensibilidad del 72,7% y especificidad del 77,5%). Conclusiones: El AA de la glucemia capilar es una herramienta que, aunque puede mejorar el control metabólico de la diabetes tipo 2, requiere una cuidadosa selección de pacientes y, por tanto, no puede utilizarse de manera indiscriminada. El tiempo de evolución de la enfermedad y, fundamentalmente, la presencia de un deficiente control metabólico de ésta deben ser los factores que determinen dicha selección. Por consiguiente, su extendido uso entre la población con diabetes tipo 2 sin una selección previa no parece estar justificada

Background and objective: The efficacy of self-measurement of capillary blood glucose (SMBG) in patients with type 2 diabetes mellitus is not fully established. The objectives of the study were: a) to verify the efficacy of the SMBG in patients with type 2 diabetes mellitus in the primary care set; b) to investigate the possible causes that explain the lack of effectiveness of the method, in their case, and c) to deduce the predictive variables that permit to select good utilizador of the SMBG. Patients and method: Clinical trial controlled and randomized carried out in the environment of the primary care, on type 2 diabetic patients. The patients were assigned, of random form and stratified, according to the type of treatment for diabetes that received, in 2 groups: SMBG group (SMBG-G) and control group (CG). The period of monitoring was of 12 months. The efficacy of the SMBG was analyzed, and also its effectiveness. Results: 100 patients were included in the study. Out of them, 51 were assigned to SMBG-G and 49 to CG. The SMBG was efficient in the 21.6% of SMBG-G and in 14.3% patients of the CG (p = 0.44). The SMBG efficacy was greater in patients with combined treatment and in those who received only insulin (50% in both cases). No improvement was observed in patients on treatment with diet (p = 0.006). The effectiveness for the cut off from value the HbA1c was of 59.2% and of 29.58% for the totality of the European criteria of metabolic control. The independent predictor variables of the SMBG efficacy were: the evolution years number of the diabetes mellitus and a deficient control of the illness at the start of the study. The global precision of the mathematical model obtained was of 88.24% with sensibility of 54.5%, especificity of 97.5%, positive predictor value of 85.7% and negative predictive value of 11.4% (p < 0.001). The area under the ROC curve was of 89.9% (p < 0.001) (95% confidence interval, 81.2-98.5%). According to the ROC curve, the point of cut that better the SMBG efficacy discriminated was that of 74% (sensibility: 72.7%; especificity: 77.5%). Conclusions: SMBG is a tool that, although can improve the metabolic control of type 2 diabetes, requires a careful selection of patients and, therefore, cannot be utilized in an indiscriminate way. The time of evolution of the illness and fundamentally, the presence of a deficient metabolic control of the disease should be the factors that determine a good selection. Therefore, its extended use among the type 2 diabetic population, without a prior selection, does not seem to be justified