NCT06031714

Brief Summary

The purpose of this study is to describe the transcriptomic profile of foetal cells in post-partum and more specifically to determine which chemokine receptors are overexpressed in foetal cells in post-partum women with wounds To do so, the investigators will isolate foetal cells from the peripheral blood of healthy controls post partum women as well as from post partum women with skin ulcers and then perform RNA sequencing.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Feb 2024Feb 2027

First Submitted

Initial submission to the registry

September 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

September 4, 2023

Last Update Submit

September 5, 2025

Conditions

Venous UlcerSickle Cell UlcerDiabetic UlcerPost-partum WomenMixed Ulcer

Keywords

MicrochimerismFoetal stem cellsReceptors

Outcome Measures

Primary Outcomes (1)

  • Transcriptomic analysis by single cell sequencing

    Transcriptomic analysis by single cell RNA sequencing (Smart-seq3 protocol) of fetal cells sorted from peripheral blood

    Month 1 up to month 5

Study Arms (3)

Patients

OTHER

Patients who have had at least one pregnancy and have a venous ulcer, diabetic ulcer or sickle cell ulcer

Other: Saliva samplingOther: Blood samplingOther: InterviewsOther: Clinical examination

Patient "Controls group "

OTHER

Post-partum women of the same age but without wounds.

Other: Saliva samplingOther: Blood samplingOther: InterviewsOther: Clinical examination

Children

OTHER
Other: Saliva sampling

Interventions

Saliva samplingOTHER

HLA genotyping. The technique should allow to identify, for children's, a paternal HLA antigen not shared with the mothers.

ChildrenPatient "Controls group "Patients
Blood samplingOTHER

Maternal Blood samples will be incubated with the appropriate antibody, targeting the microchimeric fetal cells of each patient, as well as with a cell viability marker (DAPI). The samples were then be processed through the BD FACS Aria III to sort the fetal cells, The following steps - RNA extraction, quality control, retrotranscription, preparation of the library, sequencing and transcriptomic analysis - will be carried out according to the Smart-seq3 protocol. The data will be sent for in-depth analysis and confirmation of the results. Additional functional experiments may also be carried out.

Patient "Controls group "Patients
InterviewsOTHER

V2 and/or V3

Patient "Controls group "Patients
Clinical examinationOTHER

V2 and/or V3

Patient "Controls group "Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Common criteria :
  • Adult women,
  • Post-partum: having been pregnant for any length of time,
  • Having signed a free and informed consent form,
  • Primiparous or multiparous,
  • Affiliated to a health insurance
  • Patients :
  • \- Patients with a venous, diabetic or sickle cell ulcer, or mixed ulcer
  • Control group patients :
  • Volunteers,
  • Age-matched,
  • Without skin ulcers.
  • There are no specific criteria for children.

You may not qualify if:

  • Minors (for patients)
  • Under court protection, curatorship, guardianship (for patients)
  • Immunocompromised patients for any reason whatsoever
  • Refusal of consent
  • Refusal of blood and/or saliva samples for themselves or a member of their family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology unit - Cochin Hospital - APHP

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Blood Specimen CollectionInterviews as TopicRestraint, Physical

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Sélim ARACTINGI, MD, PHD

    Dermatology unit, Cochin Hospital - APHP

    STUDY DIRECTOR

Central Study Contacts

Sélim ARACTINGI, MD, PHD

CONTACT

00 33 1 58 41 18 13selim.aractingi@aphp.fr

Marie Benhammani-Godard

CONTACT

00 33 1 58 41 11 90marie.godard@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 11, 2023

Study Start

February 6, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(1)