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

Not Applicable

Completed

• Conditions: Diabetic Foot Infection
• Interventions: Diagnostic Test: WOUNDCHEK

• Registration Number: NCT03964571
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Study Start: 2019-10-09
• Primary Completion: 2024-03-15
• Status Verified: 2024-12
• Study Completion: 2024-12-13
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic foot patients	WOUNDCHEK	-

Primary Outcome Measures

Name	Time	Method
Reduction in size of wound	From Day 0 to week 4	% change in surface area of wound; traced on OpSite Flexigrid ® film

Secondary Outcome Measures

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

Trial Locations

Locations (4)

CH d'Alès; 🇫🇷 Alès, France

CH de Bagnols sur Céze; 🇫🇷 Bagnols-sur-Cèze, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Nimes; 🇫🇷 Nîmes, France