Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) (EPOCAON)
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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 |
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Recruitment Status :
Withdrawn
(No funds)
First Posted : July 14, 2009
Last Update Posted : September 30, 2019
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Sponsor:
University of Malaga
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga
| Tracking Information | ||||||||||
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| 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 |
(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 |
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| 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:
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| 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 |
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| Condition ICMJE | Onychomycosis | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Withdrawn | |||||||||
| Actual Enrollment ICMJE |
0 | |||||||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| PRS Account | University of Malaga | |||||||||
| Verification Date | March 2010 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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