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临床试验/NCT02335931
NCT02335931已完成不适用

Follow-up on Cross-sectional Study of Known Population With Charcot Osteoarthropathy - Metabolic, Physiologic and Pathologic Changes

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Disease progression in the previously affected foot

研究概览

简要总结

The project concerns a type of very debilitating diabetic foot complications called Charcots osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of the load bearing joints, primarily in the feet, resulting in loss of structure and remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain and walking disability for the patient. Reconstruction is often very difficult or impossible, and furthermore the collapse can lead to chronic foot ulcers and infections, which in the worst case can be fatal.

Treatment options are currently limited to early diagnosis and physical offloading (immobilisation), assisted wound healing and surgical intervention.

The purpose of this project is to investigate and describe the bone-related factors, which separate COA from other, less acute, diabetic foot changes. The investigators wish to describe the long term consequences of COA - both anatomically, physiologically and biochemically.

The investigators will be doing this in a follow-up investigations on a group of COA patients tested 8 years ago. Little is known of the long term changes to the bone structure after acute COA, and the investigators want to visualize to what extend the bone damage is permanent.

To do this the investigators will be using DXA-scans, x-ray, blood tests including bone markers, neurophysiological tests and occlusion plethysmography.

详细描述

please see above

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Followed in the previous study

排除标准

  • Unable to attend follow-up

结局指标

主要结局

Disease progression in the previously affected foot

时间窗: initiation

次要结局

  • Peripheral neuropathy in the feet(initiation)
  • Altered levels of bone resorption markers(initiation)
  • Bone mineral density of os. calcaneus(initiation)
  • Peripheral blood supply(initiation)

研究者

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

Rasmus Bo Jansen

MD

Bispebjerg Hospital

研究点 (1)

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