Completed

NCT Number: NCT04777227

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intractable Plantar Keratoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Trois-Rivières, Quebec, G8Z 4M3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine injection

Drug

2% (20mg/ml) lidocaine solution

Physiological water injection

Drug

0.9% sterile sodium chloride water

Debridement

Procedure

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

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

Primary outcomes

Change from baseline in pain (visual analogue scale)

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

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)

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

The Foot Function Index (FFI) measure the impact of foot pathology on function in terms of pain, disability and activity restriction

Secondary outcomes

Change from baseline in size of Intractable plantar keratoma

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

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

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Mar 2, 2021
Registry last updated: Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.