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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine injection | Drug | 2% (20mg/ml) lidocaine solution |
| |
| 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 |
| 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 |
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Inclusion Criteria:
• Having a painful IPK for at least 3 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Cantin, PhD | Université du Québec à Trois-Rivières | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique podiatrique de l'Université du Québec à Trois-Rivières | Trois-Rivières | Quebec | G8Z 4M3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33849632 | Derived | 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. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D003646 | Debridement |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Physiological water injection |
| Drug |
0.9% sterile sodium chloride water |
|
| Debridement | Procedure | A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr. |
|
| Needle insertion | Procedure | 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 |
|
| Aniline Compounds |
| D000588 | Amines |
| D013514 | Surgical Procedures, Operative |