Lower Extremity Chronic Venous Insufficiency Clinical Trial
Official title:
Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 29, 2016 |
| Est. primary completion date | December 17, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The prevalence of onychodystrophy is higher amongst patients who present a higher degree of chronic venous disease | 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 a=0.05 to a=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. |
At baseline |