Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study

NCT04979637 | Withdrawn

• 1 other identifier: WC-20-407
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.

Conditions

Wound Infection; Wound Heal

Keywords

diabetic foot; pressure ulcer; varicose ulcer

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the combination of pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy

  This will be expressed as the diagnostic properties: positive and negative predictive values, and area under the receiver operating characteristic curve, for the three markers alone and in different combinations.

  Day 28

Secondary Outcomes (1)

• Explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.

  Day 28

Eligibility Criteria

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

Study Population

The study population will consist of eligible patients attending their regular wound care appointment with a Health Care Professional in a Clinical setting.

You may qualify if:

• Subjects with an exuding chronic wound, presenting at study sites or associated clinical or home setting
• Aged 18 years and over
• Subjects who are able and willing to provide informed consent.

You may not qualify if:

• Subjects with a wound in which it is not possible to take a wound swab:
• Wounds ≤ 2 cm2 in diameter.
• Subjects who are taking or have taken systemic antibiotics in the previous 7 days
• Wounds with scant or no exudate
• Wounds that do not have sufficient exudate to complete swab collection
• Wounds where the wound bed consists predominantly of exposed bone.
• Subjects currently confirmed positive for Methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing bacteria, Human immunodeficiency virus (HIV), hepatitis or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• Subjects on immunosuppressive or cytotoxic drugs
• Anticoagulated patients who cannot undergo wound biopsy

Sponsors & Collaborators

• ConvaTec Inc.: lead
• ClinSearch: collaborator
• Qualizyme Diagnostics GmbH & Co KG: collaborator
• Perfectus BioMed: collaborator
• Welsh Wound Innovation Centre: collaborator
• Maison de Santé Protestante de Bordeaux: collaborator

MeSH Terms

Conditions

Wound Infection; Diabetic Foot; Pressure Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Infections; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Nicky Irvins

  Welsh Wound Innovation Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 28, 2021
• Study Start: July 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 23, 2021
• Last Updated: October 7, 2022

Record last verified: 2022-10