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Trial record 20 of 38 for:    ehlers danlos

Origins and Impact of EDS in Connective Tissues and Skin

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ClinicalTrials.gov Identifier: NCT02721797
Recruitment Status : Enrolling by invitation
First Posted : March 29, 2016
Last Update Posted : May 1, 2017
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment
Ehlers-Danlos Syndrome Procedure: Orthopaedic & Gynaecology surgery

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Origins and Impact of EDS in Connective Tissues and Skin
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Skin
Patients with EDS diagnosis having surgery, have debrided skin retained for this research
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.

Tendon
Patients with EDS diagnosis having surgery, have debrided tendon retained for this research
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.

Uterine tissue
Patients with EDS diagnosis having surgery, have debrided uterine tissue retained for this research
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.

Vaginal tissue
Patients with EDS diagnosis having surgery, have debrided vaginal tissues retained for this research
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.

Ligaments
Patients with EDS diagnosis having surgery, have debrided ligaments retained for this research
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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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


  3. 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).


Biospecimen Retention:   Samples Without DNA
Collagen in skin, tendon, ligament, vaginal tissue, uterine tissue.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be identified from screening of all new and existing Hypermobility, Orthopaedics and Gynaecology clinics at UCLH and invited to participate in the study. The appropriate information sheet will be given to the patients who have been identified for elective surgery as part of their treatment plan and meeting the inclusion.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721797


Locations
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United Kingdom
University Collage Hospital
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College, London
University College London Hospitals
Investigators
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Principal Investigator: Hanna Kazkaz UCLH
Principal Investigator: Laurent Bozec UCL
Principal Investigator: Adam Strange UCL
Principal Investigator: Rodney Graham UCL
Principal Investigator: Susan Parekh UCLH

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02721797     History of Changes
Other Study ID Numbers: 15/0438
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared outside of this research

Keywords provided by University College, London:
hypermobility
collagen
joint
hyperflexation

Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases