Lower Extremity Chronic Venous InsufficiencyNCT02731222
Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs
An observational study of Lower Extremity Chronic Venous Insufficiency and Onychodystrophy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Lower Extremity Chronic Venous Insufficiency, Onychodystrophy
- What is being tested?
- observational cross-sect. analytical inferential unicentric
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2015to 29 Dec 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- observational cross-sect. analytical inferential unicentric
- Keywords
- CEAP classification, CVD: Chronic Venous Disease, Onychodystrophy, Body Mass Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational cross-sect. analytical inferential unicentricOther
Also called collecting data
collecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start9 Nov 2015
- Primary completion17 Dec 2015
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Román Escudero, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731222
- Sponsor's protocol ID
- IIBSP-ONI-2015-67
- Status last verified
- Jul 2017
- First submitted
- 24 Feb 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs
- ClinicalTrials.gov ID
- NCT02731222
- Acronym / sponsor ID
- IIBSP-ONI-2015-67
- Keywords
- CEAP classification, CVD: Chronic Venous Disease, Onychodystrophy, Body Mass Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 17 Dec 2015 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational cross-sect. analytical inferential unicentricAlso: collecting datacollecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Román Escudero, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity Chronic Venous Insufficiency and Onychodystrophy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of onychodystrophy is higher amongst patients who present a higher degree of chronic venous disease (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.