Abstract
BackgroundAn 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).MethodsA randomized single blind trial with 40 patients divided with block randomization in four parallel groups was conducted to compare treatment combinations: conservative sharp debridement only or sharp debridement with needle insertion, physiological water injection or lidocaine injection. All patients obtained the same treatment four times at a four-week interval. At each visit, visual analog scale (VAS), Foot Function Index (FFI) and IPK size were evaluated. VAS and FFI were also completed at a six and twelve-month follow-up.ResultsOur findings in regards to feasibility demonstrated recruitment challenges because of the anticipated pain that would be provoked by needle insertion may not be worth the potential pain relief compared to debridement alone from the patient’s perspective. This was also the principal cause of drop out. Our preliminary results show no main effect of group for any of the clinical outcomes: pain felt on VAS, FFI score, IPK’s size (p > 0.05). However, the analysis revealed a statistically significant effect of time on VAS (p < 0.001), FFI score (p < 0.001) and IPK’s size (width and depth (p < 0.001); length (p = 0.001)), but no group x time interaction was found (p > 0.05).ConclusionsThis study demonstrates that IPK treatment consisting of sharp debridement with needle insertion, physiological saline water injection or lidocaine injection is feasible and safe. There was a non-statistically significant trend toward diminishing pain intensity compared to scalpel debridement alone. The pain provoked by needle insertion and injection treatments must be addressed with a scientifically proven protocol to make it more comfortable for patients before these treatments could be considered in further studies.Trial registrationClinicalTrials.gov, NCT04777227. 2 March, 2021 - Retrospectively registered (All participants were recruited prior to registration).
Highlights
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
Pain intensity (VAS) and Foot Function Index (FFI)-R scores were independently subjected to a repeated-measures analysis of variance (ANOVA x r) having four levels of group (scalpel debridement alone, scalpel debridement combined with needle insertion, scalpel debridement combined with subcutaneous injection of physiological saline water (PSW) or scalpel debridement combined with subcutaneous injection of lidocaine solution (LS)) and five levels of time of measurements (baseline intervention, second intervention (T2), third intervention (T3), fourth intervention (T4), and 6-month (T6) and 12-month (T12) follow-ups)
Throughout the protocol, the major reason for dropout was anticipated pain that would be provoked by the injection
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. The elderly population is more susceptible to callosities because the loss of soft tissue is part of the aging process and atrophy of the plantar fat pad increase the plantar pressure, the pain and it limits ambulation [8,9,10] The onset of this lesion can rarely be secondary to a genetic deficiency but is, in most cases, due to repetitive trauma caused by major pressure or friction points [6, 11, 12]. It has been reported that IPK’s surgical management can lead to transfer lesions because plantar pressure points are relocated [27, 28]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
