Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study

Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospitals Geneva
Geneva
Time Frame
Start Date: 2022-10-10
Completion Date: 2023-10-31
Participants
Target number of participants: 30
Treatments
Diabetic foot ulcer with osteoarticular infections
Diabetic patients suffering from ulcer that led to an osteoarticular infection (e.g. chronic osteomyelitis, septic arthritis)
Sponsors
Leads: University Hospital, Geneva

This content was sourced from clinicaltrials.gov

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