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

Diabetic Foot Infection Clinical Trial

— CHEK BAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03964571
• Other study ID #: AOI GCS MERRI/2017/CDR-01
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Catherine Dunyach-Remy
• Phone: 04.66.68.32.02
• Email: catherine.dunyach-remy[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Infections

Intervention

Diagnostic Test:
• WOUNDCHEK
fluid swab of wound and measurement of wound onto film

Locations

Country	Name	City	State
France	CH d'Alès	Alès
France	CH de Bagnols sur Céze	Bagnols-sur-Cèze
France	CHU de Montpellier	Montpellier
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in size of wound	% change in surface area of wound; traced on OpSite Flexigrid ® film	From Day 0 to week 4
Secondary	Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 0
Secondary	Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 14
Secondary	Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 28
Secondary	Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 0, 14 and 28
Secondary	Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 14
Secondary	Presence of bacterial protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Bacterial Status	Day 28
Secondary	Clinical exam of wound	Classification as either infection or colonization according to Infectious Diseases Society of America classification	Day 0
Secondary	Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 0
Secondary	Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 14
Secondary	Presence of pathogenic bacteria in wound	Wound swabs cultured and bacteria identified	Day 28
Secondary	Reduction in size of wound	% change in surface area of wound; traced on OpSite Flexigrid ® film	From Day 0 to Week 2