search
Back to results

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

Primary Purpose

Intractable Plantar Keratoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine injection
Physiological water injection
Debridement
Needle insertion
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intractable Plantar Keratoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Experimental

Arm Label

Debridement

Debridement with needle insertion

Debridement with physiological water injection

Debridement with lidocaine injection

Arm 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

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.

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.

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.

Outcomes

Primary Outcome Measures

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"
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

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2021
Last Updated
February 25, 2021
Sponsor
Université du Québec à Trois-Rivières
search

1. Study Identification

Unique Protocol Identification Number
NCT04777227
Brief Title
Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma
Official Title
Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2015 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Plantar Keratoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Debridement
Arm Type
Active Comparator
Arm 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
Arm Title
Debridement with needle insertion
Arm Type
Sham Comparator
Arm 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.
Arm Title
Debridement with physiological water injection
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Debridement with lidocaine injection
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine injection
Intervention Description
2% (20mg/ml) lidocaine solution
Intervention Type
Drug
Intervention Name(s)
Physiological water injection
Intervention Description
0.9% sterile sodium chloride water
Intervention Type
Procedure
Intervention Name(s)
Debridement
Intervention Description
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Intervention Type
Procedure
Intervention Name(s)
Needle insertion
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in pain (visual analogue scale)
Description
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"
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
Title
Change from baseline in Foot-Function-Index-Revised (FFI-R)
Description
The Foot Function Index (FFI) measure the impact of foot pathology on function in terms of pain, disability and activity restriction
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in size of Intractable plantar keratoma
Description
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
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Cantin, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Study Director
Facility Information:
Facility Name
Clinique podiatrique de l'Université du Québec à Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 4M3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33849632
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs