Clinical trial NCT03964571: Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients
Official title: Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in size of wound
timeFrame: From Day 0 to week 4
Secondary outcomes:
measure: Presence of elevated protease activity in foot wound
timeFrame: Day 0
measure: Presence of elevated protease activity in foot wound
timeFrame: Day 14
measure: Presence of elevated protease activity in foot wound
timeFrame: Day 28
measure: Presence of bacterial protease activity in foot wound
timeFrame: Day 0, 14 and 28
measure: Presence of bacterial protease activity in foot wound
timeFrame: Day 14
measure: Presence of bacterial protease activity in foot wound
timeFrame: Day 28
measure: Clinical exam of wound
timeFrame: Day 0
measure: Presence of pathogenic bacteria in wound
timeFrame: Day 0
measure: Presence of pathogenic bacteria in wound
timeFrame: Day 14
measure: Presence of pathogenic bacteria in wound
timeFrame: Day 28
measure: Reduction in size of wound
timeFrame: From Day 0 to Week 2
Other outcomes:
Locations:
city: Alès
country: France
facility: CH d'Alès
city: Bagnols-sur-Cèze
country: France
facility: CH de Bagnols sur Céze
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Jean-Philippe Lavigne
role: PRINCIPAL_INVESTIGATOR
References: