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

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

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

Conditions
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Diabetic Foot Infection

Intervention / Treatment
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* Diagnostic Test: WOUNDCHEK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic foot patients<br> | Diagnostic Test: WOUNDCHEK<br>* fluid swab of wound and measurement of wound onto film<br>|

What is the study measuring?
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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 |