Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964571
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Diagnostic Test: WOUNDCHEK Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diabetic foot patients Diagnostic Test: WOUNDCHEK
fluid swab of wound and measurement of wound onto film




Primary Outcome Measures :
  1. Reduction in size of wound [ Time Frame: From Day 0 to week 4 ]
    % change in surface area of wound; traced on OpSite Flexigrid ® film


Secondary Outcome Measures :
  1. Presence of elevated protease activity in foot wound [ Time Frame: Day 0 ]
    Binary Yes/No; WOUNDCHEK™ Protease Status

  2. Presence of elevated protease activity in foot wound [ Time Frame: Day 14 ]
    Binary Yes/No; WOUNDCHEK™ Protease Status

  3. Presence of elevated protease activity in foot wound [ Time Frame: Day 28 ]
    Binary Yes/No; WOUNDCHEK™ Protease Status

  4. Presence of bacterial protease activity in foot wound [ Time Frame: Day 0, 14 and 28 ]
    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  5. Presence of bacterial protease activity in foot wound [ Time Frame: Day 14 ]
    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  6. Presence of bacterial protease activity in foot wound [ Time Frame: Day 28 ]
    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  7. Clinical exam of wound [ Time Frame: Day 0 ]
    Classification as either infection or colonization according to Infectious Diseases Society of America classification

  8. Presence of pathogenic bacteria in wound [ Time Frame: Day 0 ]
    Wound swabs cultured and bacteria identified

  9. Presence of pathogenic bacteria in wound [ Time Frame: Day 14 ]
    Wound swabs cultured and bacteria identified

  10. Presence of pathogenic bacteria in wound [ Time Frame: Day 28 ]
    Wound swabs cultured and bacteria identified

  11. Reduction in size of wound [ Time Frame: From Day 0 to Week 2 ]
    % change in surface area of wound; traced on OpSite Flexigrid ® film



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964571


Contacts
Layout table for location contacts
Contact: Catherine Dunyach-Remy 04.66.68.32.02 catherine.dunyach-remy@chu-nimes.fr

Locations
Layout table for location information
France
CH d'Alès Recruiting
Alès, France, 30100
Contact: Thibault Fraisse, MD    04 66 78 33 33      
Principal Investigator: Thibault Fraisse, MD         
CH de Bagnols sur Céze Recruiting
Bagnols-sur-Cèze, France, 30200
Contact: Julien Crouzet    04.66.79.78.07      
Principal Investigator: Julien Crouzet, MD         
CHU de Montpellier Recruiting
Montpellier, France, 34090
Contact: Ariane Sultan    04 67 60 46 50      
Principal Investigator: Ariane Sultan, MD         
Sub-Investigator: Julie Pochic, MD         
Sub-Investigator: Antoine Avignon, MD         
CHU de Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe Lavigne CHU Nimes
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03964571    
Other Study ID Numbers: AOI GCS MERRI/2017/CDR-01
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Focal Infection
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies