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

Tracking Information
First Submitted Date ICMJE	July 13, 2009
First Posted Date ICMJE	July 14, 2009
Last Update Posted Date	December 4, 2014
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	Complete list of historical versions of study NCT00938925 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel 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	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	Suspended
Estimated Enrollment ICMJE; (submitted: July 13, 2009)	64
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Dr. Antonio I Cuesta-Vargas, University of Malaga
Study Sponsor ICMJE	University of Malaga
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