Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) - Full Text View

Purpose

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	Intervention	Phase
Onychomycosis	Procedure: Nail lacquer plus aggressive debridement Procedure: Nail lacquer alone	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Potassium

U.S. FDA Resources

Further study details as provided by University of Malaga:

Primary Outcome Measures:

(Potassium hydroxide) KOH and cultivation negative [ Time Frame: pre and post intervention and 6 and 12 months of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938925

Locations

Spain
School Health Sciences, University of Malaga
Malaga, Málaga, Spain, 29009
Health Science School , University of Malaga
Malaga, Spain, 29009
Antonio Cuesta-vargas
Malaga, Spain, 29009

Sponsors and Collaborators

University of Malaga

Investigators

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

Additional Information:

University of Malaga This link exits the ClinicalTrials.gov site

Health Science School of University of malaga This link exits the ClinicalTrials.gov site

Regional Panel clinicals trials This link exits the ClinicalTrials.gov site

R+D Spain

No publications provided

Responsible Party:	Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga
ClinicalTrials.gov Identifier:	NCT00938925 History of Changes
Other Study ID Numbers:	03-2009
Study First Received:	July 13, 2009
Last Updated:	June 17, 2013
Health Authority:	Spain: Ethics Committee

Keywords provided by University of Malaga:

aggressive debridement
nail lacquer
onychomycosis

podiatry
chiropody
podiatry care

Additional relevant MeSH terms:

Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious

Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013