Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients (CHEK BAC)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Diabetic Foot Infection

Treatments: Diagnostic Test: WOUNDCHEK

Study type: Interventional

Funder types: Other

Identifiers

NCT03964571

AOI GCS MERRI/2017/CDR-01

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Diabetic foot patients

Experimental group

Treatment:

Diagnostic Test: WOUNDCHEK