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

NCT ID: NCT06336473

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2025-07-31

Brief Summary

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).

Detailed 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).

Conditions

Ehlers-Danlos Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Skin biopsy

Group Type: EXPERIMENTAL

skin biopsy

Intervention Type: PROCEDURE

Samples will be taken under local anaesthetic (after injection of 1 cc of Xylocaine without adrenaline) using a 4 mm diameter dermal biopsy punch. The biopsy will be performed on the buttocks. Fragments are stored in 15-mL polypropylene tubes in PBS at 4°C.

Interventions

skin biopsy

Samples will be taken under local anaesthetic (after injection of 1 cc of Xylocaine without adrenaline) using a 4 mm diameter dermal biopsy punch. The biopsy will be performed on the buttocks. Fragments are stored in 15-mL polypropylene tubes in PBS at 4°C.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Maussins-Nollet

Paris, , France

Countries

France

Central Contacts

Geoffroy NOURISSAT, MD

Role: CONTACT

gnourissat@wanadoo.fr

07 69 99 67 30 ext. 33

Other Identifiers

2023-A02097-38

Identifier Type: -

Identifier Source: org_study_id