Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections

Study Overview
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Brief Summary
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Diabetic foot ulcers are frequent with average lifetime risk of 15%, and can lead to bone and joint infections. Current protocols for their management include evaluation of ischemia, assessment of underlying bone infection, sharp debridement, off-loading and use of dressings that promote moist wound healing. Extensive debridement is optimal for wound healing and decreases the risk of recurrence. However, extension of surgical debridement is left at the clinician judgement and thus lacks standardised protocols. Plus, there is currently no known risk factors or specific biomarkers that can help guide the clinician for the extent of debridement or that can predict a recurrence in case of non-extensive debridement. The main objectives of the study are to either unravel a new biomarker, and/or identify risk factors associated with poor prognosis following surgical debridement in diabetic foot ulcers. Histones, more specifically H3.1 subtype, have been associated with sepsis. The main hypothesis is that higher blood levels of H3.1 will be present in participants showing poor prognosis (i.e., having additional surgeries, amputation, death) and that a rise in H3.1 blood levels compared to baseline (before the 1st surgical intervention) would provide an early warning of relapse or treatment failure.

Official Title
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Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study

Conditions
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Diabetic Foot, Chronic Osteomyelitis, Septic Arthritis

Intervention / Treatment
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* Diagnostic Test: Histones H3.1 blood levels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age ≥ 18 years old) suffering from diabetes mellitus (type 1 or 2) Diabetic foot ulcer with severe infection (grade 3 and 4 according to IWGDF 2019 classification) Scheduled surgical debridement Exclusion Criteria: Spondylodiscitis Pregnant or lactating women Previous enrolment in a clinical trial Consent declined by participant or tutor in case of incapacitation Tutor cannot be reached for consent in case of incapacitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic foot ulcer with osteoarticular infections<br>Diabetic patients suffering from ulcer that led to an osteoarticular infection (e.g. chronic osteomyelitis, septic arthritis) | Diagnostic Test: Histones H3.1 blood levels<br>* Measure of blood concentrations of histone subtype H3.1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical failure | Presence of infection (IWGDF 2019 criteria) and No change in H3.1 blood levels from baseline (day -1) or secondary increase after an initial decline ≥ 75% | day 30 and day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death during the study period from day-1 (day of the 1st intervention) | day 30 and day 60 | 
| Amputation rate | Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention) | day 1 to day 60 | 
| Additional surgical interventions rate | Frequency of the event 'additional surgical intervention' (i.e., debridement, amputation) as incidence rate from day-1 (day of the 1st intervention) | day 1 to day 60 | 
| Time-to-amputation | Measured in days from day-1 (day of the 1st intervention) | day 1 to day 60 | 
| Time-to-additional-intervention | Measured in days from day-1 (day of the 1st intervention) | day 1 to day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, osteoarticular infections