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CompletedNCT03964571CHEK BACUpdated Dec 18, 2024

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

An interventional study of WOUNDCHEK in Diabetic Foot Infection, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Foot Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 61 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Diabetic foot patients

    Diagnostic Test: WOUNDCHEK

Interventions

  • Diagnostic testWOUNDCHEK

    fluid swab of wound and measurement of wound onto film

06

What researchers measure

Primary outcomes

  1. Reduction in size of wound

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

    Time frame: From Day 0 to week 4

Secondary outcomes

  1. Presence of elevated protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Protease Status

    Time frame: Day 0

  2. Presence of elevated protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Protease Status

    Time frame: Day 14

  3. Presence of elevated protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Protease Status

    Time frame: Day 28

  4. Presence of bacterial protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

    Time frame: Day 0, 14 and 28

  5. Presence of bacterial protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

    Time frame: Day 14

  6. Presence of bacterial protease activity in foot wound

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

    Time frame: Day 28

  7. Clinical exam of wound

    Classification as either infection or colonization according to Infectious Diseases Society of America classification

    Time frame: Day 0

  8. Presence of pathogenic bacteria in wound

    Wound swabs cultured and bacteria identified

    Time frame: Day 0

  9. Presence of pathogenic bacteria in wound

    Wound swabs cultured and bacteria identified

    Time frame: Day 14

  10. Presence of pathogenic bacteria in wound

    Wound swabs cultured and bacteria identified

    Time frame: Day 28

  11. Reduction in size of wound

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

    Time frame: From Day 0 to Week 2

07

Study locations

4 sites
  • CH d'Alès
    Alès, 30100, France
  • CH de Bagnols sur Céze
    Bagnols-sur-Cèze, 30200, France
  • CHU de Montpellier
    Montpellier, 34090, France
  • CHU de Nimes
    Nîmes, 30029, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03964571
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Oct 9, 2019
Primary completion
Mar 15, 2024
Completion
Dec 13, 2024
Last update
Dec 18, 2024

Study contacts

Jean-Philippe Lavigne
principal investigator · CHU Nimes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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