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临床试验/NCT04668755
NCT04668755已完成不适用

Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Force platform to measure peak vertical ground reaction plantar force

研究概览

简要总结

The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.

详细描述

Foot ulcerations, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, The reduction of pressure to the Charcot foot ulcer is essential to treatment. Proper off-loading and pressure reduction prevents further trauma and promotes healing. This is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. Furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration.

  • Off-loading approaches that deal with Charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals.
  • The need of this study is developed from the lack of controlled studies that reported the therapeutic effect of Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer.
  • So the present study is designed to evaluate the Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer. Furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with Charcot neuroarthropathy.

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
Single (Investigator)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject selection will be according to the following criteria: • The patient's ages will range from 45 to 65 years.
  • Both sexes will be included in the study.
  • Informed consent for participation in this study will be obtained in writing from all patients.

排除标准

  • The potential participants will be excluded if they meet one of the following criteria:
  • Preceding surgical procedure on affected foot.
  • Patients on hemodialysis.
  • Patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.

结局指标

主要结局

Force platform to measure peak vertical ground reaction plantar force

时间窗: Three months post-intervention

Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board WBB (Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter

次要结局

  • Wound Surface area using ImageJ software(Three months post-intervention)

研究者

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

Haitham Amin Elessawy

Principal Investigator

Cairo University

研究点 (1)

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