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.
Study Type
OBSERVATIONAL
Enrollment
30
Measure of blood concentrations of histone subtype H3.1
University Hospitals Geneva
Geneva, Switzerland
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%
Time frame: day 30 and day 60
Mortality
Death during the study period from day-1 (day of the 1st intervention)
Time frame: day 30 and day 60
Amputation rate
Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention)
Time frame: 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)
Time frame: day 1 to day 60
Time-to-amputation
Measured in days from day-1 (day of the 1st intervention)
Time frame: day 1 to day 60
Time-to-additional-intervention
Measured in days from day-1 (day of the 1st intervention)
Time frame: day 1 to day 60
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