Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers.
The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.
详细描述
The study is divided into two distinct phases:
The following analysis is concerned with the characteristics of materials that are employed for the purpose of the distribution of pressure. This will entail the meticulous analysis of the response exhibited by the materials, with the objective of ascertaining their true biomechanical behaviour in volunteers devoid of active ulcers.
The materials selected in the first part will be applied for the treatment of revascularised neuroischaemic ulcers. This will determine which of the materials is the most suitable for treating the lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 55 and
- •Diagnosis of diabetes mellitus.
- •Patients with an ankle-brachial index of >0.8 and <1.
- •Signature of the informed consent form
排除标准
- •Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
- •Foot trauma within the last month.
- •Inability to adhere to the full schedule of measurements required by the study.
- •Participants who do not sign the informed consent form.
- •Known contact dermatitis to any of the study materials
研究者
Iván Julián Rochina
Associate Professor of Medicine
University of Valencia