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Completed

NCT Number: NCT03964571

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

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

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Key information

Conditions

Diabetic Foot Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'Alès, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WOUNDCHEK

Diagnostic Test

fluid swab of wound and measurement of wound onto film

Primary outcomes

  1. Reduction in size of wound

    Time frame: From Day 0 to week 4

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

Secondary outcomes

  1. Presence of elevated protease activity in foot wound

    Time frame: Day 0

    Binary Yes/No; WOUNDCHEK™ Protease Status

  2. Presence of elevated protease activity in foot wound

    Time frame: Day 14

    Binary Yes/No; WOUNDCHEK™ Protease Status

  3. Presence of elevated protease activity in foot wound

    Time frame: Day 28

    Binary Yes/No; WOUNDCHEK™ Protease Status

  4. Presence of bacterial protease activity in foot wound

    Time frame: Day 0, 14 and 28

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  5. Presence of bacterial protease activity in foot wound

    Time frame: Day 14

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  6. Presence of bacterial protease activity in foot wound

    Time frame: Day 28

    Binary Yes/No; WOUNDCHEK™ Bacterial Status

  7. Clinical exam of wound

    Time frame: Day 0

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

  8. Presence of pathogenic bacteria in wound

    Time frame: Day 0

    Wound swabs cultured and bacteria identified

  9. Presence of pathogenic bacteria in wound

    Time frame: Day 14

    Wound swabs cultured and bacteria identified

  10. Presence of pathogenic bacteria in wound

    Time frame: Day 28

    Wound swabs cultured and bacteria identified

  11. Reduction in size of wound

    Time frame: From Day 0 to Week 2

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: CHEK BAC

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 28, 2019
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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