Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma
NCT ID: NCT04777227
Last Updated: 2021-03-02
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-06-07
2019-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Debridement
A debridement (procedure involving cleaning and removing all hyperkeratotic tissue) was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr
Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Debridement with needle insertion
A debridement was followed by the insertion of a 27-gauge needle on a 3 mL syringe that was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side. The syringe was removed and the IPK was bandaged with a sterile gauze and medical tape.
Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Needle insertion
A 27-gauge needle on a 3 mL syringe was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side
Debridement with physiological water injection
A debridement was followed by the insertion of a 27-gauge needle on a 3 mL syringe that was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side. The podiatrist pressed completely on the syringe to inject 1 mL of 0.9% sterile sodium chloride water. The syringe was removed and the IPK was bandaged with a sterile gauze and medical tape.
Physiological water injection
0.9% sterile sodium chloride water
Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Debridement with lidocaine injection
A debridement was followed by the insertion of a 27-gauge needle on a 3 mL syringe that was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side. The podiatrist pressed completely on the syringe to inject 1 mL of 2% lidocaine solution. The syringe was removed and the IPK was bandaged with a sterile gauze and medical tape.
Lidocaine injection
2% (20mg/ml) lidocaine solution
Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Interventions
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Lidocaine injection
2% (20mg/ml) lidocaine solution
Physiological water injection
0.9% sterile sodium chloride water
Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Needle insertion
A 27-gauge needle on a 3 mL syringe was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe cardiovascular or neurological disease
* Immunosuppressed status
* Presence of a plantar ulcer
* Allergy to lidocaine
* History of keloid or hypertrophic scar
* Simultaneous painful plantar syndrome unrelated to the presence of an IPK
18 Years
ALL
No
Sponsors
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Université du Québec à Trois-Rivières
OTHER
Responsible Party
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Vincent Cantin
Professor
Principal Investigators
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Vincent Cantin, PhD
Role: STUDY_DIRECTOR
Université du Québec à Trois-Rivières
Locations
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Clinique podiatrique de l'Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada
Countries
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References
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Mercier MP, Blanchette V, Cantin V, Brousseau-Foley M. Effectiveness of saline water and lidocaine injection treatment of intractable plantar keratoma: a randomised feasibility study. J Foot Ankle Res. 2021 Apr 13;14(1):30. doi: 10.1186/s13047-021-00467-7.
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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