Intractable Plantar KeratomaNCT04777227

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

A study testing Lidocaine injection, Physiological water injection and Debridement in people with Intractable Plantar Keratoma, run by Université du Québec à Trois-Rivières at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intractable Plantar Keratoma
What is being tested?: Lidocaine injection, Physiological water injection and Debridement
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteCanada
Study dates: 7 Jun 2015to 15 Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Having a painful IPK for at least 3 months

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Clinique podiatrique de l'Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3

Other trials in Canada

About this study

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

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)

Conditions: Intractable Plantar Keratoma
Being tested: Lidocaine injection, Physiological water injection, Debridement, Needle insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine injectionDrug
2% (20mg/ml) lidocaine solution
Physiological water injectionDrug
0.9% sterile sodium chloride water
DebridementProcedure or surgery
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
Needle insertionProcedure or surgery
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

Study groups in NCT04777227
Study group	Role	What they receive
Debridement	Active comparator	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 Receives: Procedure: Debridement
Debridement with needle insertion	Sham comparator	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. Receives: Procedure: Debridement; Procedure: Needle insertion
Debridement with physiological water injection	Placebo comparator	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. Receives: Drug: Physiological water injection; Procedure: Debridement
Debridement with lidocaine injection	Experimental	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. Receives: Drug: Lidocaine injection; Procedure: Debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

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"
Measured: 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
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Secondary outcomes (1)

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
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201515 Sep 2019

First posted2 Mar 2021
Study start7 Jun 2015
Primary completion15 Sep 2019
Study completion15 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intractable Plantar KeratomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04777227
Sponsor's protocol ID: 001
Status last verified: Feb 2021
First submitted: 23 Feb 2021
Last updated: 2 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33849632

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study
ClinicalTrials.gov ID: NCT04777227
Acronym / sponsor ID: 001
Conditions: Intractable Plantar Keratoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Université du Québec à Trois-RivièresUniversity, hospital or other
Study start: 7 Jun 2015 (actual)
Primary completion: 15 Sep 2019 (actual)
Study completion: 15 Sep 2019 (actual)
First posted: 2 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Debridement	Active comparator	Procedure: DebridementA 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 needle insertion	Sham comparator	Procedure: Debridement, Procedure: Needle insertionA 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 physiological water injection	Placebo comparator	Drug: Physiological water injection, Procedure: DebridementA 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 lidocaine injection	Experimental	Drug: Lidocaine injection, Procedure: DebridementA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Having a painful IPK for at least 3 months

Key exclusion criteria (7 listed)

Ongoing pregnancy or breastfeeding
Severe cardiovascular or neurological disease
Immunosuppressed status
Presence of a plantar ulcer
Allergy to lidocaine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lidocaine injection2% (20mg/ml) lidocaine solution	Drug	Debridement with lidocaine injection
Physiological water injection0.9% sterile sodium chloride water	Drug	Debridement with physiological water injection
DebridementA debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.	Procedure or surgery	Debridement, Debridement with lidocaine injection, Debridement with needle insertion, Debridement with physiological water injection
Needle insertionA 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	Procedure or surgery	Debridement with needle insertion

Primary outcome

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

1 secondary outcome

Change from baseline in size of Intractable plantar keratoma
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
Derived from this study: PubMed 33849632Mercier 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vincent Cantin, PhD study director

Université du Québec à Trois-Rivières

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine injection, Physiological water injection and Debridement in people with Intractable Plantar Keratoma, run by Université du Québec à Trois-Rivières at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pain (visual analogue scale) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.