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临床试验/NCT02721797
NCT02721797Unknown不适用

Origins and Impact of EDS in Connective Tissues and Skin

University College, London1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
试验地点
1
主要终点
Histological changes in EDS compared with healthy collagen using light microscopy after staining

研究概览

简要总结

Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective tissues, such as skin. EDS patients suffer from joint and skin problems (skin hyperextensibility, joint hypermobility) along with a large range of other disorders, including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility, gastrointestinal and gum problems. There are many different types of EDS, with different mechanisms of action, and not all of these are well understood. This study will used advanced microscopy techniques called atomic force microscopy (AFM) and scanning electron microscopy (SEM) to analyse the changes in collagen as a result of EDS, compared to normal collagen. These changes will be viewed at the micron and nanoscale level (between 1,000 to 100,000 x magnification), and will focus on the differences in collagen construction through a process called cross-linking. These changes could potentially help clinicians understand the root cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in collagen. Increasing our knowledge of how collagen is affected in EDS patients, may lead to improved treatment options for patients.

研究设计

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

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

  • Adult (18+) patients requiring elective surgery as part of their treatment plan who fulfil the Brighton criteria for Joint Hypermobility Syndrome (JHS)/EDS hypermobility type with significant joint hypermobility (Beighton score of 6 and above) and /or have evidence of significant connective tissue weakness, or rectal/vaginal prolapse

排除标准

  • Patients with insufficient ability in English to give informed consent, if a translator is not present.
  • Patients with severe developmental disorders, precluding their consent for research

结局指标

主要结局

Histological changes in EDS compared with healthy collagen using light microscopy after staining

时间窗: 1-5 years

Light microscopy will be qualitatively used to observe colour changes after staining between healthy and EDS collagen

Collagen morphological changes in EDS compared with healthy collagen using AFM and SEM

时间窗: 1-5 years

AFM and SEM will be used to qualitatively observe changes in orientation in collagen.

Collagen topographical changes in EDS compared with healthy collagen using AFM and SEM

时间窗: 1-5 years

AFM and SEM will be used to observe changes in length, width and height of healthy and EDS collagen, as well as D-band length. This will be measured in meters (nm).

次要结局

  • Collagen Young's modulus changes in EDS compared with healthy collagen using AFM(1-5 years)
  • Collagen nanoscale adhesion changes in EDS compared with healthy collagen using AFM(1-5 years)
  • Collagen nanoscale single molecule pulling force in EDS compared with healthy collagen using AFM(1-5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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