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Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs

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ClinicalTrials.gov Identifier: NCT02731222
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
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.

Condition or disease Intervention/treatment
Lower Extremity Chronic Venous Insufficiency Onychodystrophy Other: observational cross-sect. analytical inferential unicentric

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Intervention Details:
  • Other: observational cross-sect. analytical inferential unicentric
    collecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau
    Other Name: collecting data


Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
After the collection of the data, the researcher will establish the variables, including all clinical data, the Doppler echography data, the CVD symptoms, and the class to which the subject belongs according to the CEAP Classification ( ranging from 0 to 6). All these data will be analyzed in relation to the presence of onychodystrophy in each patient. Other variables that can be related to onychodystrophy will also be registered: type of footwear, feet deformation, personal history and local factors considered potentially responsible for the presence of onychodystrophy. Finally, the researcher will perform the statistical analysis relating all the variables to finally determine whether there exists or not a correlation betwen (CVD) and onychodystrophy.
Criteria

Inclusion Criteria:

  • Subjects with an age ranging between 40 and 85 years.
  • Patients who attend the service of Angiology, Vascular and Endovascular Surgery with chronic venous disease in their lower limbs and presenting a clinical degree according to the CEAP Classification (Clinic, Etiology, Anatomy, Pathophysiology) ranging from C0 to C6, while at the same time manifesting or not venous reflux when exposed to an echo-Doppler scan.
  • Patients agreeing to voluntarily participate in the study who sign the informed consent document.

Exclusion Criteria:

  • Congenital Onychopathy
  • Presence in any nail plate of fungal, viral or bacterial infections
  • Emergence of digital deformities in feet
  • Manifestation of biomechanical problems
  • Presence of advanced degenerative joint disease (arthrosis, arthritis)
  • Patients who make or have made routine use of inappropriate or poorly adjusted footwear and especially those who have an onychodystrophy which is clearly and directly atributable to it
  • Individuals presenting a Greek foot and especially those that present onychodystrophy on their second toe.
  • Patients in which onychodystrophy is due to a surgical iatrogenic event
  • Individuals with existing subungual tumours (benign or malignant).
  • Patients who take or have taken any drug that causes or is directly associated with onychodystrophy
  • Patients with a history of skin diseases such as psoriasis, lichen planus or alopecia areata associated with nail manifestations.
  • Patients with a background of physical or chemical trauma on their toenails that has clearly given rise to onychodystrophy.
  • Individuals presenting any type of amputation of the lower limbs, either in the leg or the foot, including those presenting a toe amputation (total or partial).
  • Patients with a history of toenail surgery (as recent as a year or less).
  • Individuals that, despite complying with all the requirements of the study, decline to participate or refuse to sign the informed consent document.
  • People with any medical illness or psychiatric disorder which, in the opinion of the investigator, preclude them from understanding the reason for their selection or who were unable to give informed consent to their participation in the study.
  • Subjects with post-thrombotic syndrome.
  • Any affected lower limb with varicose veins having undergone surgery with any invasive procedure was excluded.
  • Patients presenting nail prosthesis or cosmetics were also excluded from the study

Information from the National Library of Medicine

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


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: José Román Escudero, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional Information:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02731222    
Other Study ID Numbers: IIBSP-ONI-2015-67
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
CEAP classification
CVD: Chronic Venous Disease
Onychodystrophy
Body Mass Index
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases