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

Study Overview
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Brief Summary
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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)

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

Conditions
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Intractable Plantar Keratoma

Intervention / Treatment
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* Drug: Lidocaine injection
* Drug: Physiological water injection
* Procedure: Debridement
* Procedure: Needle insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Debridement<br>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<br>* A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.<br>|
| Sham Comparator: Debridement with needle insertion<br>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<br>* A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.<br>Procedure: Needle insertion<br>* 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<br>|
| Placebo Comparator: Debridement with physiological water injection<br>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<br>* 0.9% sterile sodium chloride water<br>Procedure: Debridement<br>* A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.<br>|
| Experimental: Debridement with lidocaine injection<br>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<br>* 2% (20mg/ml) lidocaine solution<br>Procedure: Debridement<br>* A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |