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

NCT06336473 | Not Yet Recruiting

• 1 other identifier: 2023-A02097-38
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Ehlers-Danlos Syndrome

Outcome Measures

Primary Outcomes (1)

• 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, α the face angle of the pyramid, δ the indentation depth and ν 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 Outcomes (2)

• Collagen fibril diameter measurement

  Day 0

• Collagen fibril D-period length measurement

  Day 0

Study Arms (1)

Skin biopsy

EXPERIMENTAL

Procedure: skin biopsy

Interventions

skin biopsy 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.

Skin biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Maussins-Nollet

Paris, 75019, France

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Geoffroy NOURISSAT, MD

CONTACT

07 69 99 67 30; gnourissat@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center study performed on biopsied skin samples

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: September 3, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 31, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

FR (1)