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临床试验/NCT05593874
NCT05593874已完成不适用

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

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Clinical failure

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Clinical failure

时间窗: 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%

次要结局

  • Mortality(day 30 and day 60)
  • Amputation rate(day 1 to day 60)
  • Additional surgical interventions rate(day 1 to day 60)
  • Time-to-amputation(day 1 to day 60)
  • Time-to-additional-intervention(day 1 to day 60)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikael de Lorenzi-Tognon

Principal Subinvestigator

University Hospital, Geneva

研究点 (1)

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