Human and Bacterial Protease Activity As Prognostic Tool... | NCT03964571

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

NCT03964571

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 18, 2024Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Diabetic Foot Infection

Interventions

WOUNDCHEK

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2019Actual

Primary Completion Date

Mar 15, 2024Actual

Completion Date

Dec 13, 2024Actual

First Submitted Date

May 24, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic foot patients	Experimental		Diagnostic Test: WOUNDCHEK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WOUNDCHEK	Diagnostic Test	fluid swab of wound and measurement of wound onto film	Diabetic foot patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in size of wound	% change in surface area of wound; traced on OpSite Flexigrid ® film	From Day 0 to week 4

Secondary Outcomes

Measure	Description	Time Frame
Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status	Day 0
Presence of elevated protease activity in foot wound	Binary Yes/No; WOUNDCHEK™ Protease Status

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Philippe Lavigne	CHU Nimes	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CH d'Alès		Alès		30100	France
CH de Bagnols sur Céze

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided