Clinical Trial: Origins and Impact of EDS in Connective Tissues and Skin

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Origins and Impact of EDS in Connective Tissues and Skin

Brief Summary: 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.

Detailed Summary:
Sponsor: University College, London

Current Primary Outcome:

  • Histological changes in EDS compared with healthy collagen using light microscopy after staining [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Collagen Young's modulus changes in EDS compared with healthy collagen using AFM [ Time Frame: 1-5 years ]
    AFM will be used to calculate the Young's (elastic) modulus of the EDS and healthy collagen. This will be measured in Pascals (GPa).
  • Collagen nanoscale adhesion changes in EDS compared with healthy collagen using AFM [ Time Frame: 1-5 years ]

    AFM will be used to calculate the changes in adhesion force of the EDS and healthy collagen. This will be measured in Newtons (nN).

    Quantitative outcomes: changes in Young's (elastic) modulus, changes in adhesion force, changes in single molecule pulling force

  • Collagen nanoscale single molecule pulling force in EDS compared with healthy collagen using AFM [ Time Frame: 1-5 years ]
    AFM will be used to calculate the changes in pulling force of single molecules of EDS and healthy collagen. This will be measured in Newtons (nN).


Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: March 2, 2016
Date Started: April 1, 2017
Date Completion: April 2021
Last Updated: April 27, 2017
Last Verified: April 2017