Origins and Impact of EDS in Connective Tissues and Skin

NCT ID: NCT02721797

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ehlers-Danlos Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Skin

Patients with EDS diagnosis having surgery, have debrided skin retained for this research

Orthopaedic & Gynaecology surgery

Intervention Type PROCEDURE

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

Orthopaedic & Gynaecology surgery

Intervention Type PROCEDURE

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

Orthopaedic & Gynaecology surgery

Intervention Type PROCEDURE

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

Orthopaedic & Gynaecology surgery

Intervention Type PROCEDURE

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

Orthopaedic & Gynaecology surgery

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College London Hospitals

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanna Kazkaz

Role: PRINCIPAL_INVESTIGATOR

UCLH

Laurent Bozec

Role: PRINCIPAL_INVESTIGATOR

UCL

Adam Strange

Role: PRINCIPAL_INVESTIGATOR

UCL

Rodney Graham

Role: PRINCIPAL_INVESTIGATOR

UCL

Susan Parekh

Role: PRINCIPAL_INVESTIGATOR

UCLH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Collage Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15/0438

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.