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Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) (EPOCAON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00938925
Recruitment Status : Withdrawn (No funds)
First Posted : July 14, 2009
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga

Tracking Information
First Submitted Date  ICMJE July 13, 2009
First Posted Date  ICMJE July 14, 2009
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2009)
(Potassium hydroxide) KOH and cultivation negative [ Time Frame: pre and post intervention and 6 and 12 months of follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2009)
  • Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis) [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ]
  • Quality of life perception related the onychomycosis and foot health by nailQoL and foot health state questionnaire (FHSQ) [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ]
  • Quality of life related general health by euroQol 5-D and SF-12 [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)
Official Title  ICMJE Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
Brief Summary

Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and quality of life of the patient. Although the investigators have a wide therapeutic arsenal, there is still a disparity when carrying out an effective processing.

Hypothesis/Objectives:

To analyze if the use of the podiatric technique of aggressive unguinal abrasion with micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray, significantly increases the effectiveness clinically as well as mycology.

The investigators will analyze the relationship between this intervention and the quality perception of life related to the health of the nails and the foot.

The investigators will Use results for next validation study in Spanish of the questionnaire NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness of the processing.

Method:

The investigators will design a randomized control trial. The town will be recruited, informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with sample size of 313 patients. There will be a screening of 4 weeks to select patients with onychomycosis infections (clinic and mycology both positives); later the patients will be distributed randomly in 2 groups:

  • GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12 and 24, followed by standard treatment of amorolfin 5%, two weekly applications during 36 weeks.
  • GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according to common format. The duration will be 48 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Procedure: Nail lacquer plus aggressive debridement
    Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.
  • Procedure: Nail lacquer alone
    Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
Study Arms  ICMJE
  • Experimental: Nail lacquer plus aggressive debridement
    Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.
    Intervention: Procedure: Nail lacquer plus aggressive debridement
  • Experimental: nail lacqer alone
    Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
    Intervention: Procedure: Nail lacquer alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2009)
64
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • People of both sexes with ages between 18 and 75 years.
  • Having affected at least the nail out of the first toe of a foot.
  • Having a confirmed diagnosis of onychomycosis with positive and evidence clinic mycology (KOH and Cultivation) both positive ones.
  • The infection should be caused by a fungus dermatology. Will not afford another type of infection because of the possibility of false positives for pollution exogen.

Exclusion Criteria:

  • Having received in 6 previous months some local treatment or systemic for the onychomycosis.
  • Having dystrophies or alterations ungulates, apart from the ones specific to the onychomycosis, that could to interfere in the interpretation of results.
  • Do not have skills for the application and tracking of the topical treatment with the hairspray ungual.
  • Allergy to one of the ingredients of the nail lacquer
  • Pregnancy or breastfeeding situation acquaintances at the time of recruitment.
  • Use of some abrasive or cosmetic product (ej: nail paint) on the treated nail during the tracking of the study.
  • Receiving some type of attendance podology or of Pedicure out of the own ones included in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00938925
Other Study ID Numbers  ICMJE 03-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Antonio I Cuesta-Vargas, University of Malaga
Original Responsible Party Jose Angel Narvaez Bueno, Vice-Chancelor of University of Malaga, Research
Current Study Sponsor  ICMJE University of Malaga
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irene Garcia-Paya, DPM, MSc University of Malaga
Principal Investigator: Jose A Sanchez-Castillo, DPM, MSc University of Malaga
Study Director: Antonio I Cuesta-Vargas, PhD University of Malaga
PRS Account University of Malaga
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP