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OpenTrials
Completed

NCT Number: NCT05593874

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histones H3.1 blood levels

Diagnostic Test

Measure of blood concentrations of histone subtype H3.1

Primary outcomes

  1. Clinical failure

    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%

Secondary outcomes

  1. Mortality

    Time frame: day 30 and day 60

    Death during the study period from day-1 (day of the 1st intervention)

  2. Amputation rate

    Time frame: day 1 to day 60

    Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention)

  3. Additional surgical interventions rate

    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)

  4. Time-to-amputation

    Time frame: day 1 to day 60

    Measured in days from day-1 (day of the 1st intervention)

  5. Time-to-additional-intervention

    Time frame: day 1 to day 60

    Measured in days from day-1 (day of the 1st intervention)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
May 8, 2024

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.

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