An observational study in Diabetic Foot, Chronic Osteomyelitis and Septic Arthritis, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Hospital, Geneva · Observational
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All diabetic patients fulfilling the inclusion criteria with no exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetic patients suffering from ulcer that led to an osteoarticular infection (e.g. chronic osteomyelitis, septic arthritis)
Diagnostic Test: Histones H3.1 blood levels
Measure of blood concentrations of histone subtype H3.1
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
Plan to share: No
Ran from Oct 2022 to primary completion in Aug 2023, 10 months.
Of 65 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 94. This study's 10 months is below that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 15 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.