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

Université du Québec à Trois-Rivières

Status: Completed

Conditions: Intractable Plantar Keratoma

Treatments: Procedure: Needle insertion; Procedure: Debridement; Drug: Lidocaine injection; Drug: Physiological water injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04777227

001

Details and patient eligibility

About

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)

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Debridement

Active Comparator group

Description:

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

Treatment:

Procedure: Debridement

Debridement with needle insertion

Sham Comparator group

Description:

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.

Treatment:

Procedure: Debridement

Procedure: Needle insertion

Debridement with physiological water injection

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Debridement

Drug: Physiological water injection

Debridement with lidocaine injection

Experimental group

Description:

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.

Treatment:

Procedure: Debridement

Drug: Lidocaine injection