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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Recruitment Status : Withdrawn (No funds)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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Onychomycosis Procedure: Nail lacquer plus aggressive debridement Procedure: Nail lacquer alone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
Actual Study Start Date : October 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2017
Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Experimental: nail lacqer alone
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
 Procedure: Nail lacquer alone
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care


Outcome Measures
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Primary Outcome Measures :
  1. (Potassium hydroxide) KOH and cultivation negative [ Time Frame: pre and post intervention and 6 and 12 months of follow up ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938925


Locations
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Spain
School Health Sciences, University of Malaga
Malaga, Málaga, Spain, 29009
Antonio Cuesta-vargas
Malaga, Spain, 29009
Health Science School , University of Malaga
Malaga, Spain, 29009
Sponsors and Collaborators
University of Malaga
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT00938925    
Other Study ID Numbers: 03-2009
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: March 2010
Keywords provided by Dr. Antonio I Cuesta-Vargas, University of Malaga:
aggressive debridement
nail lacquer
onychomycosis
 podiatry
chiropody
podiatry care
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Nail Diseases
Skin Diseases