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

NCT05593874 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • Diabetic Foot
  • Chronic Osteomyelitis
  • Septic Arthritis

Interventions

DIAGNOSTIC_TEST

Histones H3.1 blood levels

Measure of blood concentrations of histone subtype H3.1

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-08-18
Completion
2023-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05593874 on ClinicalTrials.gov