Diabetic Foot Infection
Conditions
Brief summary
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
Interventions
DIAGNOSTIC_TESTWOUNDCHEK
fluid swab of wound and measurement of wound onto film
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in size of wound | From Day 0 to week 4 | % change in surface area of wound; traced on OpSite Flexigrid ® film |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of elevated protease activity in foot wound | Day 0 | Binary Yes/No; WOUNDCHEK™ Protease Status |
| Presence of bacterial protease activity in foot wound | Day 0, 14 and 28 | Binary Yes/No; WOUNDCHEK™ Bacterial Status |
| Clinical exam of wound | Day 0 | Classification as either infection or colonization according to Infectious Diseases Society of America classification |
| Presence of pathogenic bacteria in wound | Day 0 | Wound swabs cultured and bacteria identified |
| Reduction in size of wound | From Day 0 to Week 2 | % change in surface area of wound; traced on OpSite Flexigrid ® film |
Countries
France
Outcome results
None listed