Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot
- Sponsor
- University Hospital, Geneva
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical failure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Mikael de Lorenzi-Tognon
Principal Subinvestigator
University Hospital, Geneva
Eligibility Criteria
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
Outcomes
Primary Outcomes
Clinical failure
Time Frame: day 30 and day 60
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%
Secondary Outcomes
- Mortality(day 30 and day 60)
- Amputation rate(day 1 to day 60)
- Additional surgical interventions rate(day 1 to day 60)
- Time-to-amputation(day 1 to day 60)
- Time-to-additional-intervention(day 1 to day 60)