Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study.

BACKGROUND: Venous ulcers usually present a torpid evolution with a negative impact on patients' quality of life. In primary care, they account for 2.5% of nursing consultations and their treatment represents high costs for national health systems. These patients usually have a low level of physical activity, with muscle pump dysfunction of the lower limbs, which may improve with increased physical activity. The purpose of this study is to analyse the effectiveness of a structured intervention involving physical activity and exercise (Active Legs) as an adjuvant treatment in improving healing of chronic venous ulcers at 3 months follow-up. METHODS: A randomized, multicentre clinical trial. A total of 224 individuals receiving primary nursing care with a diagnosis of venous ulcer, with a diameter of 1 cm or greater and an ankle-brachial index between 0.8 and 1.3, able to comply with the study requirements and consenting to participate, will be sequentially included (112 per group). Both groups will receive the standard treatment in primary care, with cleansing, debridement and healing in a moist environment together with multilayer compression therapy. The intervention group will also receive a structured educational intervention involving lower limb physical exercise and daily ambulation guidelines. The primary response variables will be complete healing -understood as complete and sustained epithelialisation for at least 2 weeks- and time to healing. The secondary variables will be degree of healing, ulcer area, quality of life, pain and variables related to the healing process, prognosis, and recurrences. Sociodemographic variables, adherence to treatment and satisfaction variables will also be recorded. Data will be collected at baseline, at 3 months and at 6 months follow-up. Survival analysis (Kaplan-Meier and Cox) will be performed to measure primary effectiveness. Intention-to-treat analysis. DISCUSSION: If the intervention is effective, a cost-effectiveness analysis could be conducted and implemented as an additional intervention in the usual venous ulcer treatment in primary care. TRIAL REGISTRATION: NCT04039789. [ https://ClinicalTrials.gov ]. 07/11/2019.

Factors Associated With the Quality of Life of Patients With Venous Leg Ulcers in Primary Care: Cross-Sectional Study.

The presence of venous leg ulcers (VLU) is associated with emotional disorders in individuals who have conditions, such as depression, anxiety, and sleeping problems, which result in a reduced perceived quality of life by these individuals. The study aim was to describe the perceived quality of life and associated factors for individuals with VLU. We conducted a cross-sectional study in 22 primary care health centers with a sample of 93 individuals with VLU. The variables collected were the following: perceived quality of life measured with Spanish version of the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e), ulcer severity measured with the RESVECH 2.0 Score, demographic variables, and those related to the healing process. The results showed a mean CCVUQ-e score of 47.4 ± 11.8 points (Mean ± SD), with the most affected dimension being the emotional status, followed by cosmesis, social interaction, and domestic activities. The mean RESVECH 2.0 score was 11.1 ± 3.7 points. An association was found between ulcer-related pain and poorer quality of life (P < .05, t test) and between erythema in perilesional skin and poorer quality life (P < .05, t test). The signs of infection and inflammation in the VLUs were as follows: increasing exudate, friable tissue, and biofilm-compatible tissue, which were associated with a poorer quality of life (P < .05, t test). The multivariate model was statistically significant and explained a variability of 26% in the CCVUQ-e score. This study confirms that wound severity, pain, and signs of infection in VLU decrease the perceived quality of life of individuals with these wounds.

Efectividad de la terapia compresiva de doble capa frente al vendaje de crepé en la cicatrización de úlceras venosas en atención primaria. Ensayo clínico aleatorizado / Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial

OBJETIVO: Evaluar si el vendaje de 2 capas es más efectivo que el vendaje de crepé en la cicatrización de úlceras venosas tras 12 semanas de seguimiento. DISEÑO: Ensayo clínico aleatorizado multicéntrico. Emplazamiento: 22 Centros de Salud de Madrid. PARTICIPANTES: Mayores de 18 años, con diagnóstico de úlceras venosas. Se aleatorizaron 93 pacientes, 56 en el grupo de doble capa y 37 en crepé. Retiradas: 16 en el grupo de doble capa y 7 en el de crepé. INTERVENCIONES: Grupo control: práctica clínica habitual: tratamiento de la herida y vendaje con crepé. Grupo experimental: misma práctica habitual para tratamiento de la herida y vendaje con doble capa. Mediciones principales: Variable respuesta principal: cicatrización completa a las 12 semanas. Variables secundarias: severidad de las lesiones, calidad de vida, reacciones adversas. Evaluación ciega de la variable respuesta. RESULTADOS: Cicatrización completa: 25 (67%) en el grupo crepé (IC al 95% 50,2-81,9) y 32 (57,1%) en doble capa (IC al 95% 43,2-70,3). Sin diferencias en ambos grupos, RR = 1,10 (IC al 95% 0,864-1,424). La severidad de las úlceras basales se asocia al tiempo de cicatrización, HR = 0,86 (IC al 95% 0,78-0,94). Se objetiva mejora significativa en la calidad de vida total y en las dimensiones cosmesis y estado emocional. No se encuentran diferencias según el vendaje utilizado. Sin reacciones adversas graves en ninguno de los grupos. CONCLUSIONES: No encontramos diferencias significativas en la cicatrización entre los 2 tipos de vendaje. Ambos son apropiados para la cicatrización de las úlceras y para mejorar la calidad de vida

OBJECTIVE: To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up. DESIGN: Randomized multicentre controlled clinical trial. LOCATION: 22 Primary Health Centers of Madrid. PARTICIPANTS: Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group. INTERVENTIONS: Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer. Main measurements. Primary outcome: complete healing at 12 weeks. Secondary outcomes: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. RESULTS: Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR = 1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR = 0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn't find serious adverse events in any of the groups. CONCLUSIONS: We didn't find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life

[Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial]. / Efectividad de la terapia compresiva de doble capa frente al vendaje de crepé en la cicatrización de úlceras venosas en atención primaria. Ensayo clínico aleatorizado.

OBJECTIVE: To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up. DESIGN: Randomized multicentre controlled clinical trial. LOCATION: 22 Primary Health Centers of Madrid. PARTICIPANTS: Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group. INTERVENTIONS: Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer. MAIN MEASUREMENTS: Primary outcome: complete healing at 12 weeks. SECONDARY OUTCOMES: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. RESULTS: Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR=1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR=0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn't find serious adverse events in any of the groups. CONCLUSIONS: We didn't find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life.

ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol.

BACKGROUND: Chronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload. Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers. The studies we have found suggest that the use of multilayer bandage systems is more effective than the use of bandages with a single component, these are mostly using in Spain. Multilayer compression bandages with 2 layers are equally effective in the healing process of chronic venous ulcers as 4-layer bandages and are better tolerated and preferenced by patients. More studies are needed to specifically compare the 2-layer bandages systems in the settings where these patients are usually treated. METHOD/DESIGN: Randomised, controlled, parallel, multicentre clinical trial, with 12 weeks of follow-up and blind evaluation of the response variable. The objective is to assess the efficacy of multilayer compression bandages (2 layers) compared with crepe bandages, based on the incidence of healed venous ulcers in individuals treated in primary care nursing consultations, at 12 weeks of follow-up. The study will include 216 individuals (108 per branch) with venous ulcers treated in primary care nursing consultations. The primary endpoint is complete healing at 12 weeks of follow-up. The secondary endpoints are the degree of healing (Resvech.2), quality of life (CCVUQ-e), adverse reactions related to the healing process. Prognosis and demographic variables are also recorder. Effectiveness analysis using Kaplan-Meier curves, a log-rank test and a Cox regression analysis. The analysis was performed by intention to treat. DISCUSSION: The study results can contribute to improving the care and quality of life of patients with venous ulcers, decreasing healing times and healthcare expenditure and contributing to the consistent treatment of these lesions. TRIAL REGISTRATION: This study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.