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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Wound Infection; Wound Heal

Detailed Description

One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics).

To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes.

The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference.

The primary objective of the proof of concept study is to demonstrate 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.

The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.	Data obtained from the study will be analysed in order to further understand the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.	Day 28

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Collaborators: ClinSearch; Welsh Wound Innovation Centre; Qualizyme Diagnostics GmbH & Co KG; Perfectus BioMed; Maison de Santé Protestante de Bordeaux
• Investigators: Principal Investigator: Nicky Irvins, Welsh wound Innovation Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: diabetic foot; pressure ulcer; varicose ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: WC-20-407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No