Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
NCT Number: NCT02731222
The objective of this study is to determine the degree of correlation between the clinical severity of chronic venous disease and the prevalence of onychodystrophy. The completion of the study will require a previous synthetic explanation of the aforementioned two diseases, emphasizing the factors which have an impact on the proposed analysis.
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Notify Me40 year–85 year
All sexes
Observational
Barcelona, 08025, Spain
The ultimate goal of this work is to determine if patients with a higher clinical severity of chronic venous disease also present a higher prevalence of onychodystrophy. Chronic venous disease (CVD) is a vascular disease that manifests itself in the lower limbs and is related to a number of different clinical syndromes, all of which have venous hypertension (HTV) in common.
Onychodystrophy in the lower limbs is a progressive non-infectious condition associated with various factors the prevalence of which increases with age.It is mainly an acquired condition, but it can also be congenital. It is associated to a number of factors, it can sometimes be asymptomatic and it is progressive, non transmittable and evolves at a slow pace. It is characterised by an abnormal pigmentation, changes in the shape or texture and/or the deformation of nails.
The work performed was observational, cross-sectional, analytical, inferential and unicentric. In order to prove its feasibility, the researcher conducted a preliminary investigation work (pilot study) with a total of 40 patients (aged 40 to 85) who were treated at the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau (Barcelona, Spain). These patients were selected to verify their data and then the researcher performed a statistical study from a descriptive and inferential point of view to find out whether there is a relation betwen the prevalence of onychodystrophy and the degree of severity of chronic venous disease. In order to minimise methodological mistakes in the outcomes and sampling, the study has been carefully defined and framed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
collecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau
Other names: collecting data
Time frame: At baseline
The results were obtained from 83 patients, 23 men and 60 women, 40-85 years old. 120 lower limbs were analysed. All studied subjects presented CVD in the studied limb. Some presented onychodystrophy in the studied limb. Each subject was assigned a CEAP classification class (C0 to C6) depending on the severity of their CVD.
Participants were also grouped according to age and gender to establish the relation between certain variables and the degree to which their veins are affected.
We used descriptive and inferential statistics to estimate the population parameters, ensuring a significance level of α=0.05 to α=0.1, i. e. a degree of confidence of 90-95%. Given the statistical results and the degree of confidence, we think the main hypothesis ("The prevalence of onychodystrophy is higher amongst patients who present a higher degree of chronic venous disease") is proven and we can confirm the association between onychodystrophy in the lower limbs and CVD.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
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