Diabetic Foot Infection Clinical Trial
— CHEK BACOfficial title:
Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 2024 |
Est. primary completion date | September 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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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