Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.
NCT ID: NCT04654091
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2021-01-01
2021-12-31
Brief Summary
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Detailed Description
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Participants in the trial will be assigned with equal probability to each treatment arm, based on their consecutive inclusion in the study. Subsequently, the treatment allocation will be determined by a random code generated by the Epidat 4.1 program using random permuted blocks. The treatment used will be evident both for the participant and for the research podiatrist responsible for the intervention. However, the primary result will be confirmed by the microbiological study carried out by the Department of Microbiology of the Complutense University of Madrid, which does not know any data about the patient or the treatment group to which it was initially assigned.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cryoteraphy with liquid nitrogen
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
Cryoteraphy with liquid nitrogen
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of cryotherapy with liquid nitrogen will be carried out using CryoPen b® (HO Equipment, Hhislenghien-Belgium). To analyze the homogeneous application in all the patients in the study, perform 2 applications of 15 seconds per session, with an interval of 30 seconds between each application, such and as manufacturers recommend. The number of sessions in which the product is applied will be a maximum of 5, following the procedure of previous studies.
Nitric-zinc complex
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
Nitric-zinc complex
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of nitric acid-zinc complex with Verrutop® (Isdin, Barcelona-Spain) will be carried out. The preparation is applied by making small touches with the applicators included in the product.
The number of sessions in which the product is applied will be a maximum of 5, following the recommendations of the manufacturers in the product data sheet.
Interventions
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Cryoteraphy with liquid nitrogen
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of cryotherapy with liquid nitrogen will be carried out using CryoPen b® (HO Equipment, Hhislenghien-Belgium). To analyze the homogeneous application in all the patients in the study, perform 2 applications of 15 seconds per session, with an interval of 30 seconds between each application, such and as manufacturers recommend. The number of sessions in which the product is applied will be a maximum of 5, following the procedure of previous studies.
Nitric-zinc complex
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of nitric acid-zinc complex with Verrutop® (Isdin, Barcelona-Spain) will be carried out. The preparation is applied by making small touches with the applicators included in the product.
The number of sessions in which the product is applied will be a maximum of 5, following the recommendations of the manufacturers in the product data sheet.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.
Exclusion Criteria
* Peripheral vascular disease.
* Patients with an immune system disorder or in immunosuppressants treatment.
* Peripheral or central neuropathy.
* Coagulation disorders.
* Raynaud's disease or some alteration of the perception of cold or heat.
* Alterations in healing for wounds or in the synthesis of collagen.
12 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Sara García Oreja
Principal Investigator
Principal Investigators
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Francisco Javier Álvaro Afonso, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Central Contacts
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Other Identifiers
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19/471-R_X_TesisUCM
Identifier Type: -
Identifier Source: org_study_id