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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03964571
Other study ID # AOI GCS MERRI/2017/CDR-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2019
Est. completion date December 2024

Study information

Verified date June 2024
Source Centre Hospitalier Universitaire de Nimes
Contact Catherine Dunyach-Remy
Phone 04.66.68.32.02
Email catherine.dunyach-remy@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
WOUNDCHEK
fluid swab of wound and measurement of wound onto film

Locations

Country Name City State
France CH d'Alès Alès
France CH de Bagnols sur Céze Bagnols-sur-Cèze
France CHU de Montpellier Montpellier
France CHU de Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in size of wound % change in surface area of wound; traced on OpSite Flexigrid ® film From Day 0 to week 4
Secondary Presence of elevated protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Protease Status Day 0
Secondary Presence of elevated protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Protease Status Day 14
Secondary Presence of elevated protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Protease Status Day 28
Secondary Presence of bacterial protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Bacterial Status Day 0, 14 and 28
Secondary Presence of bacterial protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Bacterial Status Day 14
Secondary Presence of bacterial protease activity in foot wound Binary Yes/No; WOUNDCHEK™ Bacterial Status Day 28
Secondary Clinical exam of wound Classification as either infection or colonization according to Infectious Diseases Society of America classification Day 0
Secondary Presence of pathogenic bacteria in wound Wound swabs cultured and bacteria identified Day 0
Secondary Presence of pathogenic bacteria in wound Wound swabs cultured and bacteria identified Day 14
Secondary Presence of pathogenic bacteria in wound Wound swabs cultured and bacteria identified Day 28
Secondary Reduction in size of wound % change in surface area of wound; traced on OpSite Flexigrid ® film From Day 0 to Week 2
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