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Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients (CHEK BAC)

Primary Purpose

Diabetic Foot Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WOUNDCHEK
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Foot Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient has been informed about the study objectives and purpose and their rights as a patient
  • The patient is being treated in the Diabetes and Infectious Disease Department
  • The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America.

Exclusion Criteria:

  • The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The patient has chronic foot and/or heel wound classified as Grade 4 according to the Infectious Diseases Society of America
  • Patient with critical ischemia defined by PSGo <50 mmHg or PSCh <70 mmHg

Sites / Locations

  • CH d'AlèsRecruiting
  • CH de Bagnols sur CézeRecruiting
  • CHU de MontpellierRecruiting
  • CHU de NimesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetic foot patients

Arm Description

Outcomes

Primary Outcome Measures

Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film

Secondary Outcome Measures

Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Clinical exam of wound
Classification as either infection or colonization according to Infectious Diseases Society of America classification
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film

Full Information

First Posted
May 24, 2019
Last Updated
November 28, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03964571
Brief Title
Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
Acronym
CHEK BAC
Official Title
Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic foot patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
WOUNDCHEK
Intervention Description
fluid swab of wound and measurement of wound onto film
Primary Outcome Measure Information:
Title
Reduction in size of wound
Description
% change in surface area of wound; traced on OpSite Flexigrid ® film
Time Frame
From Day 0 to week 4
Secondary Outcome Measure Information:
Title
Presence of elevated protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Protease Status
Time Frame
Day 0
Title
Presence of elevated protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Protease Status
Time Frame
Day 14
Title
Presence of elevated protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Protease Status
Time Frame
Day 28
Title
Presence of bacterial protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time Frame
Day 0, 14 and 28
Title
Presence of bacterial protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time Frame
Day 14
Title
Presence of bacterial protease activity in foot wound
Description
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time Frame
Day 28
Title
Clinical exam of wound
Description
Classification as either infection or colonization according to Infectious Diseases Society of America classification
Time Frame
Day 0
Title
Presence of pathogenic bacteria in wound
Description
Wound swabs cultured and bacteria identified
Time Frame
Day 0
Title
Presence of pathogenic bacteria in wound
Description
Wound swabs cultured and bacteria identified
Time Frame
Day 14
Title
Presence of pathogenic bacteria in wound
Description
Wound swabs cultured and bacteria identified
Time Frame
Day 28
Title
Reduction in size of wound
Description
% change in surface area of wound; traced on OpSite Flexigrid ® film
Time Frame
From Day 0 to Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient has been informed about the study objectives and purpose and their rights as a patient The patient is being treated in the Diabetes and Infectious Disease Department The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America. Exclusion Criteria: The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship The patient is pregnant or breastfeeding The patient has chronic foot and/or heel wound classified as Grade 4 according to the Infectious Diseases Society of America Patient with critical ischemia defined by PSGo <50 mmHg or PSCh <70 mmHg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Dunyach-Remy
Phone
04.66.68.32.02
Email
catherine.dunyach-remy@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Lavigne
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Alès
City
Alès
ZIP/Postal Code
30100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault Fraisse, MD
Phone
04 66 78 33 33
First Name & Middle Initial & Last Name & Degree
Thibault Fraisse, MD
Facility Name
CH de Bagnols sur Céze
City
Bagnols-sur-Cèze
ZIP/Postal Code
30200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Crouzet
Phone
04.66.79.78.07
First Name & Middle Initial & Last Name & Degree
Julien Crouzet, MD
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariane Sultan
Phone
04 67 60 46 50
First Name & Middle Initial & Last Name & Degree
Ariane Sultan, MD
First Name & Middle Initial & Last Name & Degree
Julie Pochic, MD
First Name & Middle Initial & Last Name & Degree
Antoine Avignon, MD
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Catherine Dunyach-Remy, MD
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Lavigne, MD
First Name & Middle Initial & Last Name & Degree
Anne-Marie Guedj, MD
First Name & Middle Initial & Last Name & Degree
Olivier Gilly, MD
First Name & Middle Initial & Last Name & Degree
Albert Sotto, MD
First Name & Middle Initial & Last Name & Degree
Catherine Lechiche, MD
First Name & Middle Initial & Last Name & Degree
Elodie Verbeke, MD
First Name & Middle Initial & Last Name & Degree
Schuldiner Sophie, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients

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