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

Not Applicable

Completed

• Conditions: Intractable Plantar Keratoma
• Interventions: Drug: Physiological water injection; Procedure: Debridement; Drug: Lidocaine injection; Procedure: Needle insertion

• Registration Number: NCT04777227
• Lead Sponsor: Université du Québec à Trois-Rivières

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-07
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Debridement with physiological water injection	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.
Debridement	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
Debridement with physiological water injection	Debridement	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.
Debridement with needle insertion	Debridement	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.
Debridement with needle insertion	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.
Debridement with lidocaine injection	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.
Debridement with lidocaine injection	Debridement	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Foot-Function-Index-Revised (FFI-R)	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
Change from baseline in pain (visual analogue scale)	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"

Secondary Outcome Measures

Name	Time	Method
Change from baseline in size of Intractable plantar keratoma	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

Trial Locations

Locations (1)

Clinique podiatrique de l'Université du Québec à Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada