Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02731222|
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment|
|Lower Extremity Chronic Venous Insufficiency Onychodystrophy||Other: observational cross-sect. analytical inferential unicentric|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||40 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs|
|Actual Study Start Date :||November 9, 2015|
|Actual Primary Completion Date :||December 17, 2015|
|Actual Study Completion Date :||December 29, 2016|
- Other: observational cross-sect. analytical inferential unicentric
collecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant PauOther Name: collecting data
- The prevalence of onychodystrophy is higher amongst patients who present a higher degree of chronic venous disease [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731222
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||José Román Escudero, MD, PhD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|