Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome (SEDSKIN)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Not yet enrolling

Conditions: Ehlers-Danlos Syndrome

Treatments: Procedure: skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06336473

2023-A02097-38

Details and patient eligibility

About

The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS).

Full description

This is a single-center study based on skin biopsies. The skin biopsies will be taken at the non-vascular Ehlers-Danlos syndromes reference center at the Raymond Poincaré Hospital (Garches), by Dr. Karelle Benistan. This center regularly performs this type of biopsy as part of its routine care, and has set up a fibroblast bank for Genethon (Authorization for biological collection at Genethon: SED BACG n° DC-2021-4628).

Samples will be transported to the Centre de Recherche Saint-Antoine (UMR-S 938) where they will be processed, cut and placed on histological slides.

Atomic force microscopy analyses will be carried out at the Laboratoire de Réactivité de Surface (CNRS/Sorbonne University).

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 18 or over, having read and signed the consent form for participation in the study
• Patient with classic or hypermobile Ehlers-Danlos syndrome
• Regularly followed-up at the non-vascular Ehlers-Danlos Syndrome Reference Center at Garches Hospital.

Exclusion criteria

• Patient under court protection, guardianship or curatorship
• Pregnant or breast-feeding patient
• Patient not affiliated to the French social security system
• Impossibility of giving the subject informed information and/or written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
• Contraindication to anaesthesia or allergy to local anaesthetic product

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Skin biopsy

Experimental group

Treatment:

Procedure: skin biopsy