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

NCT ID: NCT04777227

Last Updated: 2021-03-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-07

Study Completion Date

2019-09-15

Brief Summary

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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)

Detailed Description

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Conditions

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Intractable Plantar Keratoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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

Group Type ACTIVE_COMPARATOR

Debridement

Intervention Type PROCEDURE

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.

Group Type SHAM_COMPARATOR

Debridement

Intervention Type PROCEDURE

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

Needle insertion

Intervention Type PROCEDURE

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.

Group Type PLACEBO_COMPARATOR

Physiological water injection

Intervention Type DRUG

0.9% sterile sodium chloride water

Debridement

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Lidocaine injection

Intervention Type DRUG

2% (20mg/ml) lidocaine solution

Debridement

Intervention Type PROCEDURE

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

Intervention Type DRUG

Physiological water injection

0.9% sterile sodium chloride water

Intervention Type DRUG

Debridement

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec à Trois-Rivières

OTHER

Sponsor Role lead

Responsible Party

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Vincent Cantin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Canada

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.

Reference Type DERIVED
PMID: 33849632 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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