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

NCT04777227 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Intractable Plantar Keratoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change from baseline in size of Intractable plantar keratoma

  Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Study Arms (4)

Debridement

ACTIVE COMPARATOR

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

Debridement with needle insertion

SHAM COMPARATOR

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; Procedure: Needle insertion

Debridement with physiological water injection

PLACEBO COMPARATOR

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; Procedure: Debridement

Debridement with lidocaine injection

EXPERIMENTAL

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; Procedure: Debridement

Interventions

Lidocaine injection DRUG

2% (20mg/ml) lidocaine solution

Debridement with lidocaine injection

Physiological water injection DRUG

0.9% sterile sodium chloride water

Debridement with physiological water injection

Debridement PROCEDURE

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

Debridement; Debridement with lidocaine injection; Debridement with needle insertion; Debridement with physiological water injection

Needle insertion 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 needle insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a painful IPK for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Clinique podiatrique de l'Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

Related Publications (1)

• 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.

  PMID: 33849632 DERIVED

MeSH Terms

Interventions

Lidocaine; Debridement

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Surgical Procedures, Operative

Study Officials

• Vincent Cantin, PhD

  Université du Québec à Trois-Rivières

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: June 7, 2015
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)