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临床试验/NCT03215953
NCT03215953Unknown不适用

Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Assiut University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
Reduction of mean ulcer radius

研究概览

简要总结

Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.

详细描述

Abnormal glucose metabolism gradually impairs sensation in both feet. Impaired sensation leads to recurrent attacks of inflammation "acute Charcot arthritis". Eventually, the foot becomes deformed with abnormal shape of the plantar surface. During walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. This high pressure leads to skin ulceration "pressure ulcer". These pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved.

Offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. Areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers.

The diabetic foot clinic at Assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. This clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient.

The investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, OIDFUA. This study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.

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 (Outcomes Assessor)

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

  • •Diabetes, loss of protective sensation, forefoot pressure ulcer

排除标准

  • •Ankle/Brachial index less than 0.7, severe infection

研究组 & 干预措施

Group A

Active Comparator

cast shoe plus standard wound care

干预措施: cast shoe (Device)

Group B

Active Comparator

removable walker plus standard wound care

干预措施: removable walker (Device)

结局指标

主要结局

Reduction of mean ulcer radius

时间窗: 6 months

Mean ulcer radius is √(area/π)

Severe adverse events related to use of offloading device

时间窗: 6 months

new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use

Non-severe adverse events related to use of offloading device

时间窗: 6 months

abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed

次要结局

  • Adherence(6 months)
  • Mobility(6 months)
  • Perception(6 months)
  • Lifestyle limitation(6 months)
  • severity of pain(6 months)

研究者

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

Mohammad Hasan AbdEllah

Principal Investigator

Assiut University

研究点 (1)

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