Intractable Plantar Keratoma
Conditions
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)
Interventions
2% (20mg/ml) lidocaine solution
DRUGPhysiological water injection
0.9% sterile sodium chloride water
PROCEDUREDebridement
A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
PROCEDURENeedle insertion
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
Sponsors
Université du Québec à Trois-Rivières
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed