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

Intractable Plantar Keratoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777227
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: June 7, 2015
• Est. completion date: September 15, 2019

Study information

• Verified date: February 2021
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intractable Plantar Keratoma
• Keratosis

Intervention

Drug:
• Lidocaine injection
2% (20mg/ml) lidocaine solution
• Physiological water injection
0.9% sterile sodium chloride water

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

Locations

Country	Name	City	State
Canada	Clinique podiatrique de l'Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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