Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections

University Hospitals (UH)

Status: Completed

Conditions: Diabetic Foot; Septic Arthritis; Chronic Osteomyelitis

Treatments: Diagnostic Test: Histones H3.1 blood levels

Study type: Observational

Funder types: Other

Identifiers

NCT05593874

2022-00140

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Diabetic foot ulcer with osteoarticular infections

Description:

Diabetic patients suffering from ulcer that led to an osteoarticular infection (e.g. chronic osteomyelitis, septic arthritis)

Treatment:

Diagnostic Test: Histones H3.1 blood levels