RESUMEN
INTRODUCTION: Foot blisters are a common injury, which can impact on activity and lead to infection. Increased skin surface hydration has been identified as a risk factor for blister formation, indicating that a reduction in hydration could reduce the risk of blister. METHOD: Thirty healthy adults were randomised into 3 groups, each receiving a preventative foot blister treatment (2Toms(®) Blister Shield(®); Flexitol(®) Blistop and Boots Anti-Perspirant Foot Spray). Cycles of compression and shear loads where applied to heel skin using a mechanism driven by compressed air. Temperature changes were measured during load application using a thermal imaging camera (FLIR Systems Inc. and Therm CAM™ Quick Report). Near surface hydration of the skin was measured using a Corneometer(®) (C & K, Germany). RESULTS: There was no significant difference in the rate of temperature change of the skin between the three groups compared to not using products (p = 0.767, p = 0.767, p = 0.515) or when comparing each product (p = 0.551). There was a significant decrease in near surface skin hydration, compared to baseline, after the application of powder (-8.53 AU, p = 0.01). There was no significant difference in hydration after the application of film former and antiperspirant (-1.47 AU, p = 0.26; -1.00 AU, p = 0.80, respectively). CONCLUSION: With the application of external load we found no significant difference in the effect of the three products on temperature change. The powder product demonstrated an effect on reducing the risk of blister. It is postulated that powder may have a barrier effect.
Asunto(s)
Vesícula/prevención & control , Pie , Adulto , Fricción , HumanosRESUMEN
BACKGROUND: Friction blister research has focused on prevention and treatment approaches rather than exploring the pathophysiology of the friction blister. Increased skin hydration has been purported to be a key risk factor in friction blister development. This study aimed to test the effect of increased skin surface hydration on the risk of friction blister creation. METHODS: The skin on one foot was hydrated by soaking the foot in water. Intermittent loading was carried out until an observable change of 3°C was evident using infrared thermography. The contra lateral foot acted as a control. Skin hydration and elasticity was measured using electrical capacitance and negative pressure respectively. RESULTS: The rate of temperature change of the hydrated group was significantly greater than that of the non-hydrated foot group (P = 0.001) and showed a strong positive correlation (r = 0.520) with skin surface hydration. Weak negative correlations were seen between skin elasticity and rate of temperature change in response to load application (r = -0.166) and skin surface hydration and elasticity at baseline (r = -0.195). CONCLUSION: In controlled experimental conditions increased skin surface hydration increases the rate of temperature change of the skin in response to load application and consequently increases the risk of blister creation.
Asunto(s)
Vesícula/etiología , Vesícula/fisiopatología , Agua Corporal/metabolismo , Talón/lesiones , Talón/fisiopatología , Estimulación Física , Agua/farmacología , Adolescente , Adulto , Vesícula/prevención & control , Módulo de Elasticidad , Dermatosis del Pie/fisiopatología , Dermatosis del Pie/prevención & control , Fricción , Humanos , Masculino , Factores de Riesgo , Absorción Cutánea , Temperatura Cutánea , Propiedades de Superficie , Adulto JovenRESUMEN
BACKGROUND/PURPOSE: Friction blisters on the foot are a debilitating pathology that have an impact on activities of daily living and can severely impair function. The purpose of this study was to test the hypotheses that digital infrared thermographic imaging will reveal: 1) a correlation between load application to the skin and the creation of blisters, and 2) a correlation between thermographic readings and contact thermometric temperatures. METHODS: Apparatus was developed to cause the formation of heel blisters through controlled load application (70 kPa). One foot of each of the 30 healthy volunteers (21 men and 9 women), with an age range of 31 ± 8 years, was subjected to load until a blister formed, after which load application ceased and temperature measurements were taken at set times during the following 5.5 h. Temperature measurements were also taken using a contact thermometer. RESULTS: The majority of the participants (77%) blistered within 18 min of load application. All the blisters created showed significant increases in local temperature compared to baseline during blister creation (P < 0.001) and 30 min post-blister creation (P < 0.001). There was a strong correlation between contact thermometry and thermographic temperature data (r > 8). CONCLUSION: These results suggest that thermographic images may prove useful for the remote assessment of traumatically damaged foot skin.
Asunto(s)
Vesícula/patología , Traumatismos de los Pies/patología , Fricción , Talón/lesiones , Piel/lesiones , Termografía/métodos , Adulto , Vesícula/diagnóstico por imagen , Vesícula/fisiopatología , Femenino , Traumatismos de los Pies/diagnóstico por imagen , Traumatismos de los Pies/fisiopatología , Talón/diagnóstico por imagen , Talón/patología , Humanos , Masculino , Piel/diagnóstico por imagen , Piel/patología , Temperatura Cutánea/fisiología , Traumatismos de los Tejidos Blandos/diagnóstico por imagen , Traumatismos de los Tejidos Blandos/patología , Traumatismos de los Tejidos Blandos/fisiopatología , Termografía/instrumentación , Ultrasonografía , Soporte de Peso/fisiología , Cicatrización de Heridas/fisiología , Adulto JovenRESUMEN
Aim: To generate a landscape of the current knowledge in the interventional management and outcomes of purulent skin and soft tissue infections. Design: This study is a scoping review. Methods: Electronic searches were undertaken using CINAHL, Medline, Cochrane Library, British Nursing Index, Science Direct, the National Health Service knowledge and library hub, ClinicalTrials.gov, and MedNar. The population, concept, context framework, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews were utilised, supporting a rigorous appraisal and synthesis of literature. Data Sources. The initial search and synthesis of literature were completed in January 2022 with repeat searches completed in March 2022 and July 2023. There were no imposed chronological parameters placed on the returned literature. Results: Nineteen papers were reviewed. Incision and drainage with primary closure, needle aspiration, loop drainage, catheter drainage, and suction drainage are viable adjuncts or alternatives to the traditional surgical management of skin and soft tissue abscesses. Conclusion: Despite the empirically favourable alternatives to the incision and drainage technique demonstrated, this does not appear to be driving a change in clinical practice. Future research must now look to mixed and qualitative evidence to understand the causative mechanisms of incision and drainage and its ritualistic practice. Implications. Ritual surgical practices must be challenged if nurses are to improve the treatment and management of this patient group. This will lead to further practice innovation. Impact: This study explored the challenges posed to patients, clinicians, nurses, and stakeholders, resulting from the ritualistic practice of the incision and drainage technique in purulent skin or soft tissue abscesses. Empirically and holistically viable alternatives were identified, impacting all identified entities and recommending a wider holistic study. Reporting Method. Adherence to EQUATOR guidance was achieved through the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
RESUMEN
BACKGROUND: Peripheral vascular diseases have a significant impact on functional quality of life. Previous research has demonstrated the complex, limiting and costly economic implications of these conditions such as lower limb ulceration chronicity and ischaemic amputation. These complex, limb and life threatening conditions demand the development of novel interventions with objective research as part of that development. Hence, a novel intermittent negative pressure medical device in the form of a wearable boot (FlowOx™) was developed. As part of the development process, this study aimed to explore patient and clinician opinions of the boot. METHODS: A qualitative approach was used to collect patient and clinician experiences in Norway. An advisory group informed the semi-structured questions used in seven patient interviews and one clinician focus group (n = 5). The data were recorded digitally and transcribed verbatim. Patient and clinician data were analysed as distinct groups using a thematic process. RESULTS: Data analysis resulted in five themes from the patients which gave insight into; the impact of the disease process; practicalities of using the boot, positive experiences of use; perceived outcomes; reflecting on use. Six themes were created from the clinicians. These gave insight into; ideal outcomes and how to measure them; ways to potentially use the boot; using research in healthcare; positives of the device; observed effects and next steps; potential improvements to the device. CONCLUSION: This study provides insight into the experiences and opinions of FlowOx™. Patients and clinicians were positive about the device due to its ease of use. Those patients with peripheral arterial disease experienced significantly more benefit, especially for ischaemic ulceration than those with a chronic venous condition. Clinicians placed value on the patient reported outcomes in the treatment decision-making process. This preliminary study into experiences of FlowOx™ use provides valuable feedback that will inform design modification and ongoing research into implementation points and prospective user groups. FlowOx™ demonstrates potential as a conservative therapy offering users a convenient, home use, self-care management solution for improving symptomatic peripheral arterial disease and quality of life.
Asunto(s)
Enfermedad Arterial Periférica , Calidad de Vida , Grupos Focales , Humanos , Enfermedad Arterial Periférica/terapia , Estudios Prospectivos , Investigación CualitativaRESUMEN
BACKGROUND: Critical limb ischaemia is a severe stage of lower limb peripheral artery disease which can lead to tissue loss, gangrene, amputation and death. FlowOx™ therapy is a novel negative-pressure chamber system intended for home use to increase blood flow, reduce pain and improve wound healing for patients with peripheral artery disease and critical limb ischaemia. METHODS: A Markov model was constructed to assess the relative cost-effectiveness of FlowOx™ therapy compared to standard care in lower limb peripheral artery disease patients with intermittent claudication or critical limb ischaemia. The model used data from two European trials of FlowOx™ therapy and published evidence on disease progression. From an NHS analysis perspective, various FlowOx™ therapy scenarios were modelled by adjusting the dose of FlowOx™ therapy and the amount of other care received alongside FlowOx™ therapy, in comparison to standard care. RESULTS: In the base case analysis, consisting of FlowOx™ therapy plus nominal care, the cost estimates were £12,704 for a single dose of FlowOx™ therapy per annum as compared with £15,523 for standard care. FlowOx™ therapy patients gained 0.27 additional quality adjusted life years compared to standard care patients. This equated to a dominant incremental cost-effectiveness ratio per QALY gained. At the NICE threshold WTP of £20,000 and £30,000 per QALY gained, FlowOx™ therapy in addition to standard care had a 0.80 and 1.00 probability of being cost-effectiveness respectively. CONCLUSIONS: FlowOx™ therapy delivered as a single annual dose may be a cost-effective treatment for peripheral artery disease. FlowOx™ therapy improved health outcomes and reduced treatment costs in this modelled cohort. The effectiveness and cost-effectiveness of FlowOx™ therapy is susceptible to disease severity, adherence, dose and treatment cost. Research assessing the impact of FlowOx™ therapy on NHS resource use is needed in order to provide a definitive economic evaluation.
Asunto(s)
Análisis Costo-Beneficio , Modelos Económicos , Enfermedad Arterial Periférica/terapia , Anciano , Femenino , Humanos , Masculino , Enfermedad Arterial Periférica/economía , Años de Vida Ajustados por Calidad de Vida , Resultado del TratamientoRESUMEN
Recognising structural and functional development of the paediatric foot is fundamental to ensuring a strong theoretical framework for health professionals and scientists. The transition of an infant from sitting to walking takes approximately 9 months and is when the structures and function of the foot must respond to the challenges of bearing load; becoming increasingly more essential for locomotion. Literature pertaining to the phase of development was searched. A narrative approach synthesised the information from papers written in English, with non-symptomatic infant participants up to the development stage of independent walking or two years of age. A range of literature was identified documenting morphological, physiological, neuromuscular and biomechanical aspects of the infant within this phase of development. The progression of variable gait to a regular pattern is documented within a range of studies focusing on neuromuscular control and ambulation development. However, methodological approaches may have compromised the external validity of such data. Additionally, limited consideration for the specific function and development of the foot is evident, despite its role as the primary site of weight bearing and interface with the floor. A lack of consideration of infants prior to ambulation (i.e. before cruising or walking) is also apparent which prevents a reference baseline being used effectively. This review also identifies future research priorities such that a comprehensive understanding of foot development from a non-weight bearing to a weight bearing structure during locomotor advancement can be gained.
Asunto(s)
Desarrollo Infantil/fisiología , Pie/fisiología , Caminata/fisiología , Fenómenos Biomecánicos , Humanos , Lactante , Soporte de Peso/fisiologíaRESUMEN
BACKGROUND: An improved understanding of the structural and functional development of the paediatric foot is fundamental to a strong theoretical framework for health professionals and scientists. An infant's transition from sitting, through crawling and cruising, to walking is when the structures and function of the foot must adapt to bearing load. The adaptation of skin and other hard and soft tissue, and foot and gait biomechanics, during this time is poorly understood. This is because data characterising the foot tissue and loading pre-walking onset does not exist. Of the existing kinematic and plantar pressure data, few studies have collected data which reflects the real-life activities of infants with modern equipment. METHODS: This is a longitudinal study and part of the Great Foundations Initiative, a collaborative project between the University of Brighton and the University of Salford, which is seeking to improve foot health in children. Two cohorts of 50 infants will be recruited at the two sites (University of Brighton, Eastbourne, UK and University of Salford, Salford, UK). Infants will be recruited when they first reach for their feet and attend four laboratory visits at milestones related to foot loading, with experienced independent walking being the final milestone. Data collection will include tissue characteristics (skin thickness, texture, elasticity, pH and tendon thickness and cross-sectional area), plantar pressures and kinematics captured during real world locomotion tasks. DISCUSSION: This study will provide a database characterising the development of the infant foot as it becomes a weight bearing structure. The data will allow effective comparison and quantification of changes in structure and function due to maturation and loading by measuring pre and post established walking. Additional variables which impact on the development of the foot (gender, ethnicity and body weight) will also be factored into our analysis. This will help us to advance understanding of the determinants of foot development in early childhood.
Asunto(s)
Desarrollo Infantil/fisiología , Pie/crecimiento & desarrollo , Soporte de Peso/fisiología , Adaptación Fisiológica/fisiología , Protocolos Clínicos , Pie/anatomía & histología , Pie/fisiología , Humanos , Lactante , Estudios Longitudinales , Presión , Proyectos de Investigación , Piel/crecimiento & desarrollo , Fenómenos Fisiológicos de la Piel , Caminata/fisiologíaRESUMEN
The generation of thickened plantar stratum corneum (SC) in response to elevated pressures, places individuals with diabetes at risk of ulceration. Such a response may culminate from altered biochemical and physical states of the epidermis as a result of non-enzymatic glycation (NEG). The objective of this study was to quantify specific glycation products generated in plantar epidermal proteins in individuals with Type 2 Diabetes Mellitus (T2DM) and age-matched controls (n = 103 and n = 87, respectively) and to compare these data with the viscoelastic properties (in vivo) of the epidermis. Plantar SC and venous blood samples were collected from all participants for the quantification of furosine and pentosidine using high performance liquid chromatography (HPLC). The viscoelastic properties of plantar epidermis were measured by the application of negative pressure on the surface of the skin. Plantar epidermal thickness was measured using high frequency (20 MHz) ultrasonography. There was a significantly greater concentration of pentosidine in the SC samples from people with T2DM (p = 0.001). There was no correlation between the concentration of glycated proteins in the epidermal proteins and serum proteins (furosine r = - 0.115, pentosidine r = - 0.023). The plasticity of the epidermis was significantly lower in the T2DM group than the control group (p = 0.007). The results suggest that alterations in the glycation of plantar epidermal proteins may constitute additional aggravators of ulceration in people with T2DM.
Asunto(s)
Diabetes Mellitus Tipo 2/complicaciones , Epidermis/ultraestructura , Dermatosis del Pie/etiología , Enfermedades de la Piel/etiología , Adulto , Anciano , Arginina/análogos & derivados , Arginina/análisis , Arginina/metabolismo , Biomarcadores/análisis , Estudios de Casos y Controles , Cromatografía Líquida de Alta Presión , Intervalos de Confianza , Diabetes Mellitus Tipo 2/diagnóstico , Epidermis/patología , Femenino , Dermatosis del Pie/fisiopatología , Glicosilación , Humanos , Lisina/análogos & derivados , Lisina/análisis , Lisina/metabolismo , Masculino , Persona de Mediana Edad , Valores de Referencia , Sensibilidad y Especificidad , Enfermedades de la Piel/fisiopatologíaRESUMEN
BACKGROUND: Callus is one of the most common foot skin complaints experienced by people of all ages. These painful and unsightly lesions often result in disability. The 'gold standard' of treatment is scalpel debridement by a trained specialist; however, people also seek over-the-counter remedies. There is a lack of clinical evidence for the efficacy of such products, which makes selection by patients and practitioners difficult. METHODS: This randomised, three-armed, parallel, comparative trial aimed to test the efficacy of two home treatments for plantar callus using novel, objective outcome measures (skin hydration using the capacitance method; elasticity using negative pressure application; and surface texture using imaging). Additional outcome measures were: size of callus, quality of life (Foot Health Status Questionnaire) and self-reported participant satisfaction and compliance. The results were compared to a podiatry treatment. Participants were randomly allocated to one of three groups: potassium hydroxide (KOH, 40 %); trichloroacetic acid (TCA); and podiatry treatment. Participants were followed for 3 weeks after their initial intervention appointment (days 7, 14 and 21). The primary outcomes were the change from baseline in callus hydration, elasticity, texture, and size at each of the three time points. The secondary outcomes where: change in quality of life 21 days after treatment; resolution of calluses via visual inspection; and participant compliance and perception. RESULTS: Forty-six participants (61 ft) with plantar calluses were recruited. The podiatry treatment showed immediate and significant changes in all objective outcomes, associated foot pain and function (p <0.01). Lesser changes in skin quality and perceived pain and functional benefits occurred with TCA and KOH over 21 days. CONCLUSIONS: This is the first study where objective outcome measures have been used to measure changes in the nature of skin in response to callus treatments. We found significant differences in plantar callus in response to podiatry and two home treatments. The podiatry treatment showed immediate and significant changes in skin and associated foot pain and function. Lesser, but sometimes comparable, changes in skin and perceived pain and functional benefits occurred with TCA and KOH over 21 days. TRIAL REGISTRATION: ISRCTN14751843 : date of registration: 30 April 2015.
Asunto(s)
Callosidades/terapia , Cáusticos/administración & dosificación , Desbridamiento , Enfermedades del Pie/terapia , Hidróxidos/administración & dosificación , Podiatría/métodos , Compuestos de Potasio/administración & dosificación , Piel , Ácido Tricloroacético/administración & dosificación , Administración Cutánea , Adulto , Anciano , Callosidades/diagnóstico , Callosidades/fisiopatología , Cáusticos/efectos adversos , Desbridamiento/efectos adversos , Elasticidad , Inglaterra , Femenino , Enfermedades del Pie/diagnóstico , Enfermedades del Pie/fisiopatología , Humanos , Hidróxidos/efectos adversos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Cooperación del Paciente , Satisfacción del Paciente , Compuestos de Potasio/efectos adversos , Calidad de Vida , Piel/metabolismo , Piel/patología , Piel/fisiopatología , Fenómenos Fisiológicos de la Piel , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Ácido Tricloroacético/efectos adversos , Agua/metabolismo , Adulto JovenRESUMEN
BACKGROUND: Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. METHODS: We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen's kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. RESULTS: Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. CONCLUSIONS: Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori. TRIAL REGISTRATION: ISRCTN Registry ISRCTN18994246.
Asunto(s)
Enfermedades del Pie/terapia , Evaluación de Resultado en la Atención de Salud/métodos , Verrugas/terapia , Adolescente , Adulto , Anciano , Niño , Crioterapia , Femenino , Enfermedades del Pie/tratamiento farmacológico , Humanos , Queratolíticos/uso terapéutico , Masculino , Persona de Mediana Edad , Fotograbar/métodos , Proyectos de Investigación , Ácido Salicílico/uso terapéutico , Autocuidado/métodos , Autoinforme , Método Simple Ciego , Resultado del Tratamiento , Verrugas/tratamiento farmacológico , Adulto JovenRESUMEN
BACKGROUND: Hyperkeratosis of foot skin is a common skin problem affecting people of different ages. The clinical presentation of this condition can range from dry flaky skin, which can lead to fissures, to hard callused skin which is often painful and debilitating. The purpose of this study was to test the reliability of certain non-invasive skin measurement devices on foot skin in normal and hyperkeratotic states, with a view to confirming their use as quantitative outcome measures in future clinical trials. METHODS: Twelve healthy adult participants with a range of foot skin conditions (xerotic skin, heel fissures and plantar calluses) were recruited to the study. Measurements of normal and hyperkeratotic skin sites were taken using the following devices: Corneometer® CM 825, Cutometer® 580 MPA, Reviscometer® RVM 600, Visioline® VL 650 Quantiride® and Visioscan® VC 98, by two investigators on two consecutive days. The intra and inter rater reliability and standard error of measurement for each device was calculated. RESULTS: The data revealed the majority of the devices to be reliable measurement tools for normal and hyperkeratotic foot skin (ICC values > 0.6). The surface evaluation parameters for skin: SEsc and SEsm have greater reliability compared to the SEr measure. The Cutometer® is sensitive to soft tissue movement within the probe, therefore measurement of plantar soft tissue areas should be approached with caution. Reviscometer® measures on callused skin demonstrated an unusually high degree of error. CONCLUSIONS: These results confirm the intra and inter rater reliability of the Corneometer®, Cutometer®, Visioline® and Visioscan® in quantifying specific foot skin biophysical properties.
RESUMEN
BACKGROUND: Plantar foot skin exhibits unique biophysical properties that are distinct from skin on other areas of the body. This paper characterises, using non-invasive methods, the biophysical properties of foot skin in healthy and pathological states including xerosis, heel fissures, calluses and corns. METHODS: Ninety three people participated. Skin hydration, elasticity, collagen and elastin fibre organisation and surface texture was measured from plantar calluses, corns, fissured heel skin and xerotic heel skin. Previously published criteria were applied to classify the severity of each skin lesion and differences in the biophysical properties compared between each classification. RESULTS: Calluses, corns, xerotic heel skin and heel fissures had significantly lower levels of hydration; less elasticity and greater surface texture than unaffected skin sites (p < 0.01). Some evidence was found for a positive correlation between hydration and elasticity data (r ≤ 0.65) at hyperkeratotic sites. Significant differences in skin properties (with the exception of texture) were noted between different classifications of skin lesion. CONCLUSIONS: This study provides benchmark data for healthy and different severities of pathological foot skin. These data have applications ranging from monitoring the quality of foot skin, to measuring the efficacy of therapeutic interventions.
RESUMEN
INTRODUCTION: Verrucae are extremely common, and are experienced by most people at some time during their lives. Although most verrucae will spontaneously disappear without treatment, many patients seek treatment, often because they have persisted for many years, are unsightly or painful or prevent them from doing sports or other activities. There are many different treatments available; including the Falknor's needling procedure. To date, there has only been one small trial evaluating the clinical effectiveness of this treatment and no health economic analysis has been undertaken. The Effective Verruca Treatments (EVerT2) trial aims to evaluate the clinical and cost-effectiveness of the needling procedure for the treatment of verrucae. METHODS AND ANALYSIS: This single-centre randomised controlled trial will recruit 58 participants (aged 18â years and over with a plantar verruca) from Salford Podiatry Clinic patient lists and the surrounding area. If the participant presents with multiple verrucae, an 'index' verruca (largest and thickest lesion) will be identified and patients will be randomised 1:1 to the intervention group to receive the needling treatment or the control group to have the callus overlying the verruca debrided. The primary outcome is complete clearance of the index verruca at 12â weeks after randomisation. Secondary outcomes include clearance and recurrence of the treated verruca, clearance of all verrucae, number of verrucae remaining, change in size of the index verruca, pain, and participant satisfaction. A cost-effectiveness analysis of the needling versus callus debridement will be carried out from the perspective of health services over a time horizon of 12â weeks. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of Salford, Department of Health Sciences Ethical Approval Committee (HSCR15/24) and the University of York, Department of Health Sciences Research Governance Committee (HSRGC/2014/98/B). Findings will be disseminated through publication and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN16429440.
Asunto(s)
Análisis Costo-Beneficio , Desbridamiento/métodos , Agujas , Evaluación de Resultado en la Atención de Salud , Piel/patología , Verrugas/terapia , Protocolos Clínicos , Humanos , Proyectos de InvestigaciónRESUMEN
BACKGROUND: Amongst the many identified mechanisms leading to diabetic foot ulceration, ill-fitting footwear is one. There is anecdotal evidence that people with diabetic peripheral neuropathy wear shoes that are too small in order to increase the sensation of fit. The aim of this study was to determine whether people with diabetic sensory neuropathy wear appropriate length footwear. METHODS: A case-control design was used to compare internal shoe length and foot length differences between a group of people with diabetes and peripheral sensory neuropathy and a group of people without diabetes and no peripheral sensory neuropathy. Shoe and foot length measurements were taken using a calibrated Internal Shoe Size Gauge® and a Brannock Device®, respectively. RESULTS: Data was collected from 85 participants with diabetes and 118 participants without diabetes. The mean difference between shoe and foot length was not significantly different between the two groups. However, a significant number of participants within both groups had a shoe to foot length difference that lay outside a previously suggested 10 to 15 mm range. From the diabetic and non-diabetic groups 82% (70/85) and 66% (78/118), respectively had a foot to shoe length difference outside this same range. CONCLUSIONS: This study shows that although there is no significant difference in shoe-length fit between participants with and without neuropathy, a significant proportion of these populations wear shoes that are either too long or too short for their foot length according to the 10 to 15 mm value used for comparison. The study has highlighted the need for standardised approaches when considering the allowance required between foot and internal shoe length and for the measurement and comparison of foot and shoe dimensions.
RESUMEN
BACKGROUND: Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient's preference on outcome measures. The aims of this study were to examine whether patients' treatment preference affected clearance of plantar warts and explore whether there were any associations between patients' treatment preference and baseline variables in the EverT trial. METHODS: Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher's exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient's self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group. RESULTS: Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) CONCLUSIONS: This secondary analysis showed no evidence to suggest that patients' baseline preferences affected verruca clearance rates or adherence with the treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151.
RESUMEN
BACKGROUND: Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. METHODS: A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. RESULTS: Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. CONCLUSIONS: Cryotherapy is more costly and no more effective than salicylic acid. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.
RESUMEN
Posterior tibial tendon dysfunction is a progressive deformity that can result in the development of a pathologic flatfoot deformity. Numerous publications have studied the effects of clinical interventions at specific stages of progression of posterior tibial tendon dysfunction, but there is still uncertainty regarding the clinical identification of the condition. It is clear that more information regarding the etiology, progression, and risk factors of posterior tibial tendon dysfunction is required. Clear evidence exists that suggests that the quality of life for patients with posterior tibial tendon dysfunction is significantly affected. Furthermore, evidence suggests that early conservative intervention can significantly improve quality of life regarding disability, function, and pain. This would suggest that significant cost burden reductions could be made by improving awareness of the condition, which would improve early diagnosis. Early conservative intervention may help reduce the number of patients requiring surgery. This review focuses on the etiologic factors, epidemiologic features, and pathogenesis of posterior tibial tendon dysfunction. It aims to analyze, discuss, and debate the current understanding of this condition using the available literature. In addition, there is a discussion of the evidence base surrounding disease characteristics associated with the different clinical stages of posterior tibial tendon dysfunction.
Asunto(s)
Pie Plano , Procedimientos de Cirugía Plástica/métodos , Disfunción del Tendón Tibial Posterior , Progresión de la Enfermedad , Pie Plano/etiología , Pie Plano/fisiopatología , Pie Plano/cirugía , Marcha/fisiología , Humanos , Disfunción del Tendón Tibial Posterior/complicaciones , Disfunción del Tendón Tibial Posterior/diagnóstico , Disfunción del Tendón Tibial Posterior/fisiopatologíaRESUMEN
The vascular and cutaneous alterations evident in systemic sclerosis/scleroderma (SSc) place the foot at risk of ulceration. The UK Podiatry Rheumatic Care Association (PRCA)/Arthritis and Musculoskeletal Alliance standards of care recommend that all people with SSc should receive at least basic information about their foot health, and that those with foot problems should have access to self-management advice and care where needed. The aim of this study was to evaluate foot health services offered in Leeds (UK) for people with SSc, against nationally agreed standards of care. Ninety-one consecutive patients with SSc were selected from either the connective tissue disease outpatient clinic (n = 70) or the specialist rheumatology foot health clinic (n = 21) at Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust. All the patients completed a disease-specific audit tool developed by the UK PRCA that evaluates provision of foot health care for patients with SSc. Sixty-one patients (67%) reported having had foot problems at some point in time and 54 (59%) had current foot problems. Of these 54 patients, 17 (32%) had not received any foot care. Only 36 (39%) of the 91 patients had received any foot health information. This audit demonstrates that patients with SSc have a relatively high prevalence of self-reported foot problems. Foot health care and information are inadequate for people with SSc and foot problems, and preventative information is almost non-existent. Improved foot health information will better empower patients to self-manage low risk problems, and help identify high risk problems which require specialist care.
Asunto(s)
Enfermedades del Pie/terapia , Necesidades y Demandas de Servicios de Salud/estadística & datos numéricos , Podiatría/normas , Esclerodermia Sistémica/terapia , Adulto , Anciano , Anciano de 80 o más Años , Auditoría Clínica , Inglaterra/epidemiología , Femenino , Enfermedades del Pie/epidemiología , Encuestas de Atención de la Salud , Accesibilidad a los Servicios de Salud , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Prevalencia , Esclerodermia Sistémica/epidemiología , Encuestas y Cuestionarios , Adulto JovenRESUMEN
OBJECTIVE: To compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts. DESIGN: A multicentre, open, two arm randomised controlled trial. SETTING: University podiatry school clinics, NHS podiatry clinics, and primary care in England, Scotland, and Ireland. PARTICIPANTS: 240 patients aged 12 years and over, with a plantar wart that in the opinion of the healthcare professional was suitable for treatment with both cryotherapy and salicylic acid. INTERVENTIONS: Cryotherapy with liquid nitrogen delivered by a healthcare professional, up to four treatments two to three weeks apart. Patient self treatment with 50% salicylic acid (Verrugon) daily up to a maximum of eight weeks. MAIN OUTCOME MEASURES: Complete clearance of all plantar warts at 12 weeks. Secondary outcomes were (a) complete clearance of all plantar warts at 12 weeks controlling for age, whether the wart had been treated previously, and type of wart, (b) patient self reported clearance of plantar warts at six months, (c) time to clearance of plantar wart, (d) number of plantar warts at 12 weeks, and (e) patient satisfaction with the treatment. RESULTS: There was no evidence of a difference between the salicylic acid and cryotherapy groups in the proportions of participants with complete clearance of all plantar warts at 12 weeks (17/119 (14%) v 15/110 (14%), difference 0.65% (95% CI -8.33 to 9.63), P=0.89). The results did not change when the analysis was repeated but with adjustment for age, whether the wart had been treated previously, and type of plantar wart or for patients' preferences at baseline. There was no evidence of a difference between the salicylic acid and cryotherapy groups in self reported clearance of plantar warts at six months (29/95 (31%) v 33/98 (34%), difference -3.15% (-16.31 to 10.02), P=0.64) or in time to clearance (hazard ratio 0.80 (95% CI 0.51 to 1.25), P=0.33). There was also no evidence of a difference in the number of plantar warts at 12 weeks (incident rate ratio 1.08 (0.81 to 1.43), P=0.62). CONCLUSIONS: Salicylic acid and the cryotherapy were equally effective for clearance of plantar warts. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18994246, National Research Register N0484189151.