Ehlers-Danlos SyndromeNCT02721797
Origins and Impact of EDS in Connective Tissues and Skin
An observational study of Ehlers-Danlos Syndrome, run by University College, London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- Orthopaedic & Gynaecology surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- Orthopaedic & Gynaecology surgery
- Keywords
- hypermobility, collagen, joint, hyperflexation
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic & Gynaecology surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Skin | Patients with EDS diagnosis having surgery, have debrided skin retained for this research Receives: Procedure: Orthopaedic & Gynaecology surgery | |
| Tendon | Patients with EDS diagnosis having surgery, have debrided tendon retained for this research Receives: Procedure: Orthopaedic & Gynaecology surgery | |
| Uterine tissue | Patients with EDS diagnosis having surgery, have debrided uterine tissue retained for this research Receives: Procedure: Orthopaedic & Gynaecology surgery | |
| Vaginal tissue | Patients with EDS diagnosis having surgery, have debrided vaginal tissues retained for this research Receives: Procedure: Orthopaedic & Gynaecology surgery | |
| Ligaments | Patients with EDS diagnosis having surgery, have debrided ligaments retained for this research Receives: Procedure: Orthopaedic & Gynaecology surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 1-5 years
Secondary outcomes (3)
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).
Measured: 1-5 years
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
Measured: 1-5 years
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).
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start1 Apr 2017
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Hanna Kazkaz, Principal investigator, University College London HospitalsLaurent Bozec, Principal investigator, UCLAdam Strange, Principal investigator, UCLRodney Graham, Principal investigator, UCLSusan Parekh, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721797
- Sponsor's protocol ID
- 15/0438
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data will be shared outside of this research
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Origins and Impact of EDS in Connective Tissues and Skin
- ClinicalTrials.gov ID
- NCT02721797
- Acronym / sponsor ID
- 15/0438
- Conditions
- Ehlers-Danlos Syndrome
- Keywords
- hypermobility, collagen, joint, hyperflexation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Skin | – | Procedure: Orthopaedic & Gynaecology surgeryPatients with EDS diagnosis having surgery, have debrided skin retained for this research |
| Tendon | – | Procedure: Orthopaedic & Gynaecology surgeryPatients with EDS diagnosis having surgery, have debrided tendon retained for this research |
| Uterine tissue | – | Procedure: Orthopaedic & Gynaecology surgeryPatients with EDS diagnosis having surgery, have debrided uterine tissue retained for this research |
| Vaginal tissue | – | Procedure: Orthopaedic & Gynaecology surgeryPatients with EDS diagnosis having surgery, have debrided vaginal tissues retained for this research |
| Ligaments | – | Procedure: Orthopaedic & Gynaecology surgeryPatients with EDS diagnosis having surgery, have debrided ligaments retained for this research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopaedic & Gynaecology surgeryPatients 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. | Procedure or surgery | Ligaments, Skin, Tendon, Uterine tissue, Vaginal tissue |
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).
3 secondary outcomes
Collagen Young's modulus changes in EDS compared with healthy collagen using AFM
Time frame: 1-5 years
Collagen nanoscale adhesion changes in EDS compared with healthy collagen using AFM
Time frame: 1-5 years
Collagen nanoscale single molecule pulling force in EDS compared with healthy collagen using AFM
Time frame: 1-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No. No data will be shared outside of this research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Kazkaz principal investigator
University College London Hospitals
Laurent Bozec principal investigator
UCL
Adam Strange principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers-Danlos Syndrome, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological changes in EDS compared with healthy collagen using light microscopy after staining (time frame: 1-5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.