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

Completed

• Conditions: Diabetic Foot; Chronic Osteomyelitis; Septic Arthritis
• Interventions: Diagnostic Test: Histones H3.1 blood levels

• Registration Number: NCT05593874
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-25
• Primary Completion: 2023-08-18
• Study Completion: 2023-10-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic foot ulcer with osteoarticular infections	Histones H3.1 blood levels	Diabetic patients suffering from ulcer that led to an osteoarticular infection (e.g. chronic osteomyelitis, septic arthritis)

Primary Outcome Measures

Name	Time	Method
Clinical failure	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 Outcome Measures

Name	Time	Method
Time-to-additional-intervention	day 1 to day 60	Measured in days from day-1 (day of the 1st intervention)
Mortality	day 30 and day 60	Death during the study period from day-1 (day of the 1st intervention)
Amputation rate	day 1 to day 60	Frequency of the event 'amputation' as incidence rate from day-1 (day of the 1st intervention)
Additional surgical interventions rate	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)
Time-to-amputation	day 1 to day 60	Measured in days from day-1 (day of the 1st intervention)

Trial Locations

Locations (1)

University Hospitals Geneva; 🇨🇭 Geneva, Switzerland