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NCT05593874 | COMPLETED | Diabetic Foot


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

University Hospital, Geneva

Information provided by (Responsible Party):

Mikael of Lorenzi-Tognon

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.

Condition or disease

Diabetic Foot

Chronic Osteomyelitis

Septic Arthritis

Intervention/treatment

Histones H3.1 blood levels

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
Official Title : Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections - a Monocentric Prospective Observational Cohort Study
Actual Study Start Date : 2022-10-10
Estimated Primary Completion Date : 2023-08-18
Estimated Study Completion Date : 2023-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT05593874


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Locations


Not yet recruiting

Switzerland,

University Hospitals Geneva

Geneva, Switzerland, 1211

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