NL-OMON52177招募中不适用
An integrated personalised assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST) - Personalised assistive devices approach for diabetic foot ulcer prevention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diabetes mellitus type 1 or 2
- •2. Age 18 years or above
- •3. Loss of protective sensation based on the presence of peripheral neuropathy
- •4. A healed plantar foot ulcer or foot amputation in the preceding 4 years
- •until two weeks before study inclusion
- •5. In possession of custom-made orthopaedic shoes, defined as *Orthopaedic
- •shoes type A* or *Orthopaedic shoes type B* , or Orthopaedic Provision in
- •Regular Footwear (OVAC), according to the Dutch healthcare system
- •6. Ability to provide informed consent
排除标准
- •1. Foot ulcer or open amputation site(s)
- •2. Active Charcot*s neuroarthropathy
- •3. Foot infection, based on criteria of the PEDIS classification
- •4. Amputation proximal to the metatarsal bones in both feet
- •5. Ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4
- •years, as surgical intervention (flexor tenotomy) is a more likely and
- •guideline-recommended treatment for such patients, rather than the multimodal
- •care under investigation
- •6. Severe illness that would make 12-months survival unlikely, based on the
- •clinical judgment by the physician
- •7. Concomitant severe physical or mental conditions that limit the ability to
- •follow instructions for the study, based on the clinical judgment by the
研究者
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