University Hospitals Geneva
Geneva, 1211, Switzerland
NCT Number: NCT05593874
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Geneva, 1211, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measure of blood concentrations of histone subtype H3.1
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%
Time frame: day 30 and day 60
Death during the study period from day-1 (day of the 1st intervention)
Time frame: day 1 to day 60
Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention)
Time frame: 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 frame: day 1 to day 60
Measured in days from day-1 (day of the 1st intervention)
Time frame: day 1 to day 60
Measured in days from day-1 (day of the 1st intervention)
University Hospital, Geneva
Other
Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07690566
Cardiovascular Diseases, Diabetes Complications
Minya, Egypt
View Trial DetailsNCT05579743
Cardiovascular Diseases, Diabetes Complications
Baltimore, Maryland, United States
View Trial DetailsNCT02378493
Bacterial Infections, Bacterial Infections and Mycoses
Clermont-Ferrand, France
View Trial DetailsNCT07553468
Cardiovascular Diseases, Diabetes Complications
León, León Department, Nicaragua
View Trial Details