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

NCT03964571 | Completed

• 1 other identifier: AOI GCS MERRI/2017/CDR-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (1)

• Reduction in size of wound

  % change in surface area of wound; traced on OpSite Flexigrid ® film

  From Day 0 to week 4

Secondary Outcomes (11)

• Presence of elevated protease activity in foot wound

  Day 0

• Presence of elevated protease activity in foot wound

  Day 14

• Presence of elevated protease activity in foot wound

  Day 28

• Presence of bacterial protease activity in foot wound

  Day 0, 14 and 28

• Presence of bacterial protease activity in foot wound

  Day 14

Study Arms (1)

Diabetic foot patients

EXPERIMENTAL

Diagnostic Test: WOUNDCHEK

Interventions

WOUNDCHEK DIAGNOSTIC_TEST

fluid swab of wound and measurement of wound onto film

Diabetic foot patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

CH d'Alès

Alès, 30100, France

Location

CH de Bagnols sur Céze

Bagnols-sur-Cèze, 30200, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

CHU de Nimes

Nîmes, 30029, France

Location

Study Officials

• Jean-Philippe Lavigne

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: October 9, 2019
• Primary Completion: March 15, 2024
• Study Completion: December 13, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)