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

Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study

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)

Study Overview

• Status: Completed
• Conditions: Intractable Plantar Keratoma
• Intervention / Treatment: Procedure: Debridement; Procedure: Needle insertion; Drug: Physiological water injection; Drug: Lidocaine injection

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8Z 4M3
      • Clinique podiatrique de l'Université du Québec à Trois-Rivières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.	Procedure: Debridement; A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.; Drug: Physiological water injection; 0.9% sterile sodium chloride water
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.	Procedure: Debridement; A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.; Drug: Lidocaine injection; 2% (20mg/ml) lidocaine solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pain (visual analogue scale)	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"	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
Change from baseline in Foot-Function-Index-Revised (FFI-R)	The Foot Function Index (FFI) measure the impact of foot pathology on function in terms of pain, disability and activity restriction	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in size of Intractable plantar keratoma	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	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières
• Investigators: Study Director: Vincent Cantin, PhD, Université du Québec à Trois-Rivières

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2015
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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