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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

March 2, 2016

Completed

27 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed

1 year until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed

Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

March 2, 2016

Last Update Submit

March 25, 2020

Conditions

Ehlers-Danlos Syndrome

Keywords

hypermobilitycollagenjointhyperflexation

Outcome Measures

Primary Outcomes (3)

Histological changes in EDS compared with healthy collagen using light microscopy after staining
Light microscopy will be qualitatively used to observe colour changes after staining between healthy and EDS collagen
1-5 years
Collagen morphological changes in EDS compared with healthy collagen using AFM and SEM
AFM and SEM will be used to qualitatively observe changes in orientation in collagen.
1-5 years
Collagen topographical changes in EDS compared with healthy collagen using AFM and SEM
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).
1-5 years

Secondary Outcomes (3)

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