Origins and Impact of EDS in Connective Tissues and Skin

Ehlers-Danlos Syndrome Clinical Trial

Official title:

Origins and Impact of EDS in Connective Tissues and Skin

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02721797
• Other study ID #: 15/0438
• Status: Enrolling by invitation
• Start date: April 1, 2017
• Est. completion date: April 2021

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: April 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome

Intervention

Procedure:
• Orthopaedic & Gynaecology surgery
Patients will have the surgery they require for their treatment. During surgery, debrided tissues will be retained for research. No treatment plans will be altered for this research.

Locations

Country	Name	City	State
United Kingdom	University Collage Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Collagen Young's modulus changes in EDS compared with healthy collagen using AFM	AFM will be used to calculate the Young's (elastic) modulus of the EDS and healthy collagen. This will be measured in Pascals (GPa).	1-5 years
Secondary	Collagen nanoscale adhesion changes in EDS compared with healthy collagen using AFM	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	1-5 years
Secondary	Collagen nanoscale single molecule pulling force in EDS compared with healthy collagen using AFM	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).	1-5 years