NCT02842502

Brief Summary

This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

3.5 years

First QC Date

July 18, 2016

Last Update Submit

July 22, 2016

Conditions

Leg Ulcer

Keywords

Skin Substitutes

Outcome Measures

Primary Outcomes (1)

  • Number of skin substitute reconstructed with cells isolated from patient biopsies

    1 year

Study Arms (1)

Skin graft pellet

EXPERIMENTAL

This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.

Procedure: Collection of supernumerary biopsies during skin graft pellet procedure

Interventions

Collection of supernumerary biopsies during skin graft pellet procedurePROCEDURE
Skin graft pellet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with chronic leg ulcers evolving for more than 6 months
  • Patient to receive skin pellet transplant
  • Chronic wound area between 10 and 30 cm²

You may not qualify if:

  • Patient without health insurance,
  • Pregnant womens,
  • Smoking patient,
  • Chronic wound area \>30 cm²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Philippe Humbert, MD PhD

    University Hospital of Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Humbert, MD, PhD

CONTACT

phumbert@chu-besancon.fr

Gwenael Rolin, PhD

CONTACT

0033381219164grolin@chu-besancon.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

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 25, 2016

Study Start

September 1, 2014

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

July 25, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

FR(1)