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Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma

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ClinicalTrials.gov Identifier: NCT04777227
Recruitment Status : Completed
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Vincent Cantin, Université du Québec à Trois-Rivières

Brief Summary:
An intractable plantar keratoma (IPK) is a conical thickening of the epidermis' stratum corneum and a common cause of foot pain which can have a significant, detrimental impact on the mobility, quality of life and independence of individuals. Conservative treatments are currently offered to patients with IPK, but they are unsatisfactory since they do not offer a sufficient or permanent reduction of symptoms. The purpose of this study was the evaluation of the feasibility, safety and effectiveness of innovative treatments for intractable plantar keratoma (IPK)

Condition or disease Intervention/treatment Phase
Intractable Plantar Keratoma Drug: Lidocaine injection Drug: Physiological water injection Procedure: Debridement Procedure: Needle insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study
Actual Study Start Date : June 7, 2015
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Active Comparator: 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
Procedure: Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.

Sham Comparator: 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.
Procedure: Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.

Procedure: 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

Placebo Comparator: 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.
Drug: Physiological water injection
0.9% sterile sodium chloride water

Procedure: Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.

Experimental: 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.
Drug: Lidocaine injection
2% (20mg/ml) lidocaine solution

Procedure: Debridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.




Primary Outcome Measures :
  1. Change from baseline in pain (visual analogue scale) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months ]
    Patients were asked to rate their pain level during the seven previous days on the visual analogue scale (VAS). The VAS is a 10 centimeters line anchored at the beginning by "no pain" and at the end by "worst pain imaginable"

  2. Change from baseline in Foot-Function-Index-Revised (FFI-R) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months ]
    The Foot Function Index (FFI) measure the impact of foot pathology on function in terms of pain, disability and activity restriction


Secondary Outcome Measures :
  1. Change from baseline in size of Intractable plantar keratoma [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months ]
    IPK's length and width was measured with a millimeter scale ruler used in wound care (accuracy ± 0.1 mm). The depth was estimated with a cotton tip applicator technique measured with the same ruler



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Having a painful IPK for at least 3 months

Exclusion Criteria:

  • Ongoing pregnancy or breastfeeding
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777227


Locations
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Canada, Quebec
Clinique podiatrique de l'Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 4M3
Sponsors and Collaborators
Université du Québec à Trois-Rivières
Investigators
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Study Director: Vincent Cantin, PhD Université du Québec à Trois-Rivières
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vincent Cantin, Professor, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier: NCT04777227    
Other Study ID Numbers: 001
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Keratosis
Skin Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action