Clinical trial NCT05593874: Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections
Official title: Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Chronic Osteomyelitis
Septic Arthritis
Keywords: diabetic foot
osteoarticular infections
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetic patients fulfilling the inclusion criteria with no exclusion criteria.

Brief 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 criteria: 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

Primary outcomes:
measure: Clinical failure
timeFrame: day 30 and day 60
Secondary outcomes:
measure: Mortality
timeFrame: day 30 and day 60
measure: Amputation rate
timeFrame: day 1 to day 60
measure: Additional surgical interventions rate
timeFrame: day 1 to day 60
measure: Time-to-amputation
timeFrame: day 1 to day 60
measure: Time-to-additional-intervention
timeFrame: day 1 to day 60
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals Geneva
Study officials:
References:
citation: Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.
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citation: Eichhorn T, Linsberger I, Laukova L, Tripisciano C, Fendl B, Weiss R, Konig F, Valicek G, Miestinger G, Hormann C, Weber V. Analysis of Inflammatory Mediator Profiles in Sepsis Patients Reveals That Extracellular Histones Are Strongly Elevated in Nonsurvivors. Mediators Inflamm. 2021 Mar 17;2021:8395048. doi: 10.1155/2021/8395048. eCollection 2021.
citation: Morimont L, Dechamps M, David C, Bouvy C, Gillot C, Haguet H, Favresse J, Ronvaux L, Candiracci J, Herzog M, Laterre PF, De Poortere J, Horman S, Beauloye C, Douxfils J. NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study. Biomolecules. 2022 Jul 27;12(8):1038. doi: 10.3390/biom12081038.