This trial is active, not recruiting.

Conditions lower extremity chronic venous insufficiency, onychodystrophy
Treatment observational - statistical / one single group
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Start date November 2015
End date June 2016
Trial size 40 participants
Trial identifier NCT02731222, IIBSP-ONI-2015-67


The objective of the present study is to determine the degree of correlation between clinical severity of chronic venous insufficiency and prevalence of onychodystrophy. The achievement of the study will require previously a synthetic exposition of the two diseases, emphasizing those factors affecting the proposed analysis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective cross-sectional

Primary Outcomes

Prevalence of onychodystrophy
time frame: At baseline
Prevalence of onychodystrophy in Patients with CVD (chronic venous disease)
time frame: At baseline

Secondary Outcomes

Prevalence of onychodystrophy, in patients with CVD
time frame: At baseline

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Subjects with an age range between 40 and 80 years. - Patients who attend the service of Angiology, Vascular Surgery and Endovascular with chronic venous disease or chronic venous insufficiency in lower extremity and presenting a clinical degree among C0 to C6 scale of the classification CEAP (Clinic-Etiology - Anatomy-Pathophysiology) while at the same time they manifest venous reflux, when exposed to the echo-Doppler scan. - Patients agreeing to voluntarily participate in the study and that sign the informed consent document. Exclusion Criteria: - Congenital Onychopathy - Presence in any nail plate of fungal, viral or bacterial infections - Emergence of digital foot deformities - Manifestation of biomechanical problems - Presence of degenerative joint disease (arthrosis, arthritis) - Patients who make or have made routine use of inappropriate or poorly adjusted footwear and especially, those who have onychodystrophy attributable clearly, and directly to the footwear - Individuals presenting a Greek foot and especially, those that manifest this onychodystrophy in the second toe. - Patients in which onychodystrophy is due to surgical iatrogenic event - Individuals presenting subungual tumours (exostosis, tumor Glomus, chondroma, whitlow melanic). - Patients who take or have taken any drug that is directly associated with a cause of onychodystrophy - Patients with a history of skin diseases such as psoriasis, Lichen Planus or alopecia areata, that are associated in general with nail manifestations. - Patients with a background of physical or chemical trauma on the nails of the feet that have clearly given rise to onychodystrophy. - Individuals, who have any type of amputation of the lower limbs. - Patients with a history of nail foot surgery (less than a year) or showing any digital amputation (total or partial). - 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 understand the reason for the selection or were unable to give informed consent to participate in the study - Subjects with post-thrombotic syndrome. - The affected lower limb with varicose veins that has undergone surgery with any invasive procedure will be excluded. - Patients presenting prosthesis or nail cosmetics are also excluded of the study

Additional Information

Official title Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of Lower Limbs
Principal investigator Jose Roman Escudero, MD, PhD
Description The final goal of this work is to determine if patients with increased clinical severity of chronic venous insufficiency have also a higher prevalence of onychodystrophy. Chronic Venous Insufficiency (CVI) is a vascular disease that responds to a number of different clinical syndromes and is manifested in the lower extremity, whose nexus is venous hypertension (HTV). Onychodystrophy on the feet is a progressive non-infectious condition associated with various factors, which increases with age. Predominantly occurs in females, presents poor aesthetic appearance and often annoyed with footwear. The work that is intended to perform is observational, descriptive, analytical, cross-sectional and unicentric. In order to prove the feasibility, the researcher will conduct a previous pilot study. The study will undertake a preliminary investigation work (pilot study) to be performed with a total of 40 patients who are attending the service of Angiology and Vascular Surgery of the Hospital de Sant Pau. These will be selected consecutively to verify the distribution and determine the "n" or sample size needed to estimate the prevalence of onychodystrophy in patients and to determine if it is different according to the degree of severity of the CVI.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.