Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in Foot-Function-Index-Revised (FFI-R)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a painful IPK for at least 3 months
排除标准
- •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
研究组 & 干预措施
Debridement
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
干预措施: Debridement (Procedure)
Debridement with needle insertion
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.
干预措施: Debridement (Procedure)
Debridement with needle insertion
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.
干预措施: Needle insertion (Procedure)
Debridement with physiological water injection
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.
干预措施: Physiological water injection (Drug)
Debridement with physiological water injection
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.
干预措施: Debridement (Procedure)
Debridement with lidocaine injection
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.
干预措施: Lidocaine injection (Drug)
Debridement with lidocaine injection
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.
干预措施: Debridement (Procedure)
结局指标
主要结局
Change from baseline in Foot-Function-Index-Revised (FFI-R)
时间窗: 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
Change from baseline in pain (visual analogue scale)
时间窗: 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"
次要结局
- Change from baseline in size of Intractable plantar keratoma(Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months)
研究者
Vincent Cantin
Professor
Université du Québec à Trois-Rivières