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Factors Associated With Dermatoporosis (FAWD)

30. august 2021 opdateret af: Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.

The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.

An observational, cross-sectional, descriptive, and analytical study was performed. Patients >60 years old were selected. A clinical history, clinical examination, and application of a validated diagnostic self-questionnaire were performed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.The objective was to determine factors associated with this diagnosis in >60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.

An observational, cross-sectional, descriptive and analytical study was performed. Through consecutive non-probabilistic sampling, patients > 60 years old were selected, who underwent a clinical history, clinical examination, and the application of a validated diagnostic self-questionnaire. To determine the association of the factors, a multivariate logistic regression analysis, it will be used the PRIMERv6 software with the PERMANOVA package. A p <0.05 was considered significant. The normality of the distribution of the continuous variables was evaluated with the Shapiro Wilk test. The Student's t test was performed on variables that met the homogeneity of variance requirements. In the variables that did not meet this criterion, a non-parametric analysis was performed with the Mann U Whitney test. For the analysis of categorical variables, Fisher's exact test or chi-square test was used. Continuous variables were reported by mean (median) [Q1, Q3] (min - max) and by standard deviations as their distribution corresponds. Nominal categorical variables were expressed as frequencies

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

315

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
      • San Luis Potosi, Mexico, 78220
        • Hospital Central "Dr. Ignacio Morones Prieto"

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients over 60 years of age who attended the outpatient clinic of the Hospital Central "Dr. Ignacio Morones Prieto "

Beskrivelse

Inclusion Criteria:

  • Patients over 60 years

Exclusion Criteria:

  • Patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc.
  • Patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit.
  • Patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cases
Patients diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.
Andet: Questionnaire about associated factors
Questionnaire about age, prolonged sun exposure, intake of anticoagulants / antiplatelets, intake of oral steroids, chronic kidney disease. Maternal age> 40 years in their last child , time of lactation per pregnancy and cumulative time of lactation. Age of the first pregnancy and age of menopause onset.
Diagnostisk test: Self questionnaire diagnostic tool
Self questionnaire of physical characteristics
Andet: Physical Examination
Physical Examination made by a dermatologist
Control
Patients not diagnosed with dermatoporosis. A clinical history, physical examination, and application of a previously validated diagnostic self-questionnaire were performed.
Andet: Questionnaire about associated factors
Questionnaire about age, prolonged sun exposure, intake of anticoagulants / antiplatelets, intake of oral steroids, chronic kidney disease. Maternal age> 40 years in their last child , time of lactation per pregnancy and cumulative time of lactation. Age of the first pregnancy and age of menopause onset.
Diagnostisk test: Self questionnaire diagnostic tool
Self questionnaire of physical characteristics
Andet: Physical Examination
Physical Examination made by a dermatologist

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Factors associated with Dermatoporosis
Tidsramme: At time of enrollment
Presence of factors related to age, sex, personal history of diseases, chronic oral treatments, gyneco-obstetrics background, chronic photoexposure
At time of enrollment
Diagnostic by self assesment tool
Tidsramme: At time of enrollment
Diagnostic of dermatoporosis made by self assesment tool
At time of enrollment
Physical examination
Tidsramme: At time of enrollment
Presence of pseudoscars (stellate scars) in the physical examination
At time of enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de San Luis Potosí

Efterforskere

  • Ledende efterforsker: Juan Pablo Castanedo-Cazares, PhD, Universidad Autonoma de San Luis Potosí

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2018

Primær færdiggørelse (Faktiske)

30. november 2018

Studieafslutning (Faktiske)

30. april 2019

Datoer for studieregistrering

Først indsendt

23. august 2021

Først indsendt, der opfyldte QC-kriterier

30. august 2021

Først opslået (Faktiske)

8. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FactorsDermatoporosis

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Database of 315 patients diagnosed and not diagnosed with dermatoporosis will be shared for 3 years. It includes associated factors, physical examination and results of self assesment tool.

IPD-delingstidsramme

3 years

IPD-delingsadgangskriterier

The database will be shared with researchers who require it by means of a letter sent to the principle investigator justifying its use for research and attaching a letter that describes the privacy policy to safeguard the information contained in the database.

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)
  • Analytisk kode

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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