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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Infection
• Intervention / Treatment: Diagnostic test: WOUNDCHEK

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Dunyach-Remy; Phone Number: 04.66.68.32.02; Email: catherine.dunyach-remy@chu-nimes.fr

Study Locations

• France
  • Alès, France, 30100
    • Recruiting
    • CH d'Alès
    • Contact: Thibault Fraisse, MD; Phone Number: 04 66 78 33 33
    • Principal Investigator: Thibault Fraisse, MD
  • Bagnols-sur-Cèze, France, 30200
    • Recruiting
    • CH de Bagnols sur Céze
    • Contact: Julien Crouzet; Phone Number: 04.66.79.78.07
    • Principal Investigator: Julien Crouzet, MD
  • Montpellier, France, 34090
    • Recruiting
    • CHU de Montpellier
    • Contact: Ariane Sultan; Phone Number: 04 67 60 46 50
    • Principal Investigator: Ariane Sultan, MD
    • Sub-Investigator: Julie Pochic, MD
    • Sub-Investigator: Antoine Avignon, MD
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nimes
    • Sub-Investigator: Catherine Dunyach-Remy, MD
    • Principal Investigator: Jean-Philippe Lavigne, MD
    • Sub-Investigator: Anne-Marie Guedj, MD
    • Sub-Investigator: Olivier Gilly, MD
    • Sub-Investigator: Albert Sotto, MD
    • Sub-Investigator: Catherine Lechiche, MD
    • Sub-Investigator: Elodie Verbeke, MD
    • Sub-Investigator: Schuldiner Sophie, MD
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic foot patients	Diagnostic test: WOUNDCHEK; fluid swab of wound and measurement of wound onto film

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in size of wound	% change in surface area of wound; traced on OpSite Flexigrid ® film	From Day 0 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 0
Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 14
Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 28
Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 0, 14 and 28
Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 14
Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 28
Clinical exam of wound	Classification as either infection or colonization according to Infectious Diseases Society of America classification	Day 0
Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 0
Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 14
Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 28
Reduction in size of wound	% change in surface area of wound; traced on OpSite Flexigrid ® film	From Day 0 to Week 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-Philippe Lavigne, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Infections; Communicable Diseases; Focal Infection
• Other Study ID Numbers: AOI GCS MERRI/2017/CDR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No