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Not Yet RecruitingNCT06336473

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREskin biopsySamples 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.

Timeline

Start date
2024-09-03
Primary completion
2025-04-01
Completion
2025-07-31
First posted
2024-03-28
Last updated
2024-06-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06336473. Inclusion in this directory is not an endorsement.