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临床试验/NCT06357884
NCT06357884已完成不适用

Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Peak plantar pressure (PPP) (unit: kPa)

研究概览

简要总结

Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •Age 18 or older
  • •Active out-patient status in Podiatry department of Princess Margaret Hospital
  • •Men and women
  • •Diagnosis of type I or II diabetes
  • •Failed peripheral neurological assessment (Vibration perception threshold >25 volts or unable to detect one or more sites of 4-point 10g Semmes-Weinstein monofilament test)
  • •Presence of plantar callus
  • •Compliance with instructions (in Chinese or english)
  • •Ability to read and write (in Chinese or english)

排除标准

  • •Peripheral vascular disease
  • •Painful neuropathy
  • •Charcot deformity
  • •Undergone any form of callus debridement in the past 6 weeks
  • •Active foot ulcer
  • •Any dermatological condition other than callus that causes hyperkeratosis (e.g. verruca pedis, eczema, tinea pedis)
  • •Any musculoskeletal condition that affects balance and gait
  • •Allergic to chlorhexidine gluconate or alcohol

研究组 & 干预措施

Callus debridement

Experimental

Callus debridement which aligns with routine clinical practice of the Princess Margaret Hospital Podiatry Department.

干预措施: Callus debridement (Procedure)

结局指标

主要结局

Peak plantar pressure (PPP) (unit: kPa)

时间窗: Before treatment, immediately after treatment and 3-4 weeks post-treatment

The maximum or highest pressure within foot

次要结局

  • Forefoot to rearfoot peak pressure ratio (F/R ratio)(Before treatment, immediately after treatment and 3-4 weeks post-treatment)
  • Foot and Ankle Outcome Score (FAOS)(Before treatment, 1 week after treatment and 3-4 weeks post-treatment)
  • Peak pressure gradient (PPG) (unit: kPa/cm)(Before treatment, immediately after treatment and 3-4 weeks post-treatment)
  • Pressure time integral (PTI) (unit: kPa*sec)(Before treatment, immediately after treatment and 3-4 weeks post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Tze Yan LAI

MSc Student

Chinese University of Hong Kong

研究点 (1)

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