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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nail lacquer plus aggressive debridement | Experimental | 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. |
|
| nail lacqer alone | Experimental | Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nail lacquer plus aggressive debridement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| (Potassium hydroxide) KOH and cultivation negative | pre and post intervention and 6 and 12 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Garcia-Paya, DPM, MSc | University of Malaga | Principal Investigator |
| Jose A Sanchez-Castillo, DPM, MSc | University of Malaga | Principal Investigator |
| Antonio I Cuesta-Vargas, PhD | University of Malaga | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School Health Sciences, University of Malaga | Málaga | Málaga | 29009 | Spain | ||
| Antonio Cuesta-vargas |
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| Label | URL |
|---|---|
| University of Malaga | View source |
| Regional Panel clinicals trials | View source |
| R+D Spain |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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|
| Nail lacquer alone | Procedure | Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care |
|
| 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 | total score, pre and post intervention and 6 and 12 months of follow up |
| Málaga |
| 29009 |
| Spain |
| Health Science School , University of Malaga | Málaga | 29009 | Spain |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |