Chronic Osteomyelitis, Diabetic Foot, Septic Arthritis
Conditions
Keywords
diabetic foot, osteoarticular infections
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.
Interventions
DIAGNOSTIC_TESTHistones H3.1 blood levels
Measure of blood concentrations of histone subtype H3.1
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical failure | 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | day 30 and day 60 | Death during the study period from day-1 (day of the 1st intervention) |
| Amputation rate | day 1 to day 60 | Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention) |
| Additional surgical interventions rate | day 1 to day 60 | Frequency of the event 'additional surgical intervention' (i.e., debridement, amputation) as incidence rate from day-1 (day of the 1st intervention) |
| Time-to-amputation | day 1 to day 60 | Measured in days from day-1 (day of the 1st intervention) |
| Time-to-additional-intervention | day 1 to day 60 | Measured in days from day-1 (day of the 1st intervention) |
Countries
Switzerland
Outcome results
None listed