NCT02519166

Brief Summary

In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

July 28, 2015

Last Update Submit

November 19, 2025

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (2)

  • Clinical examination

    1 month

  • characterisation of biofilm by fluorescence microscopy and confocal

    1 month

Study Arms (1)

Patients with chronic wounds

OTHER
Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing

Interventions

1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbingBIOLOGICAL
Patients with chronic wounds

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic wounds (period \> 6 weeks) \> 10 cm2
  • Patient age \>18 for the 3 French centres
  • Patient participation in a follow-up program for treatment of their wound \> 1 month
  • Availability of patient information and written informed consent from them or their legal representative

You may not qualify if:

  • Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
  • Patients deprived of freedom or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chu Montpellier

Montpellier, 34000, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Rothschild

Paris, 75012, France

Location

Study Design

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

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 10, 2015

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

FR(3)