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

NCT ID: NCT03964571

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2024-12-13

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Foot Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diabetic foot patients

Group Type EXPERIMENTAL

WOUNDCHEK

Intervention Type DIAGNOSTIC_TEST

fluid swab of wound and measurement of wound onto film

Interventions

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WOUNDCHEK

fluid swab of wound and measurement of wound onto film

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Lavigne

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CH d'Alès

Alès, , France

Site Status

CH de Bagnols sur Céze

Bagnols-sur-Cèze, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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AOI GCS MERRI/2017/CDR-01

Identifier Type: -

Identifier Source: org_study_id