This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
61
fluid swab of wound and measurement of wound onto film
CH d'Alès
Alès, France
CH de Bagnols sur Céze
Bagnols-sur-Cèze, France
CHU de Montpellier
Montpellier, France
CHU de Nimes
Nîmes, France
Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film
Time frame: From Day 0 to week 4
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Time frame: Day 0
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Time frame: Day 14
Presence of elevated protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Protease Status
Time frame: Day 28
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time frame: Day 0, 14 and 28
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time frame: Day 14
Presence of bacterial protease activity in foot wound
Binary Yes/No; WOUNDCHEK™ Bacterial Status
Time frame: Day 28
Clinical exam of wound
Classification as either infection or colonization according to Infectious Diseases Society of America classification
Time frame: Day 0
Presence of pathogenic bacteria in wound
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Wound swabs cultured and bacteria identified
Time frame: Day 0
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Time frame: Day 14
Presence of pathogenic bacteria in wound
Wound swabs cultured and bacteria identified
Time frame: Day 28
Reduction in size of wound
% change in surface area of wound; traced on OpSite Flexigrid ® film
Time frame: From Day 0 to Week 2