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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • skin biopsy

    Procedure/Surgery

    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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Skin biopsyExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Day 0

Secondary outcomes

1

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.

Time frame
Day 0
2

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.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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