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

Ehlers-Danlos Syndrome Clinical Trial

— SEDSKIN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336473
• Other study ID #: 2023-A02097-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Geoffroy NOURISSAT, MD
• Phone: 07 69 99 67 30
• Email: gnourissat[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: July 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Clinique Maussins-Nollet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young's modulus quantification	Atomic force microscopy (AFM), in contact mode, enables force curves to be obtained. The tip no longer scans the surface of the sample, but probes the surface at several indentation points.; A microlever deflection curve is generated for each indentation point.; Calculation of Young's modulus is based on Bilodeau's model, in which the tip is assimilated to a pyramid in contact with a flat surface.; F is the measured force, E the modulus of elasticity, a the face angle of the pyramid, d the indentation depth and ? the Poisson's ratio of the sample, set at 0.5 (corresponding to an incompressible material).; Young's modulus will be quantified by AFM	Day 0
Secondary	Collagen fibril diameter measurement	Three 2 µm x 2 µm images with at least 100 scan lines will be acquired on each sample and used to describe the intrinsic characteristics of collagen fibrils.	Day 0
Secondary	Collagen fibril D-period length measurement	Three 2 µm x 2 µm images with at least 100 scan lines will be acquired on each sample and used to describe the intrinsic characteristics of collagen fibrils.	Day 0